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Chemistry Manufacturing and Controls- Regulatory Challenges and Solution
2
Featured Speaker
Dr Mandakini Goel
Sr Solution Consultant South Asia
Clarivate Analytics
3
Agenda
4
6
7
8
15
1 Health for Allhellip
2 Regulatory Approval Processes- Challenges and Implications
3 Why CMC
4 Common Challenges for CMC professionals-Deep Dive
5 Use Cases
4
Sustainable Development Goal 38 of the United Nations-promotion of health through expanded access to quality assured medicines
Health for Allhellip
Manufacturing controls amp Quality assurance systems are the foundation for assuring quality products
Challenge is the easy access of up-to-date manufacturing control requirements- LMIC countries
- Lower and middle income countries
5
Global burden of diseases-
bull Malaria ndash 90 of the cases were in the WHO African Region followed by the WHO South-East Asia Region (7) and the WHO Eastern Mediterranean Region (2) Of the 91 countries reporting indigenous malaria cases in 2016 15 countries ndash all in sub-Saharan Africa except India ndash carried 80 of the global malaria burden
bull Tuberculosis- 86 million new cases
bull HIV- 80 of people living with HIV
Regulatory Challenges-
bull Navigation of regulatory requirements
bull Location and Interpretation of CMC requirements
bull Variations in regional requirements
bull Varying levels of regulatory enforcement maturity
bull Lack of awareness
Why LMICs
6
Many manufacturersrsquo use regulatory programmes such as WHO Prequalification Programme (PQ) and USFDArsquos PEPFAR tentative approval pathway However individual countryrsquos approval through National Regulatory Authority might be required to launch the drugs in country of interest to ensure that the products entering these markets are safe efficacious and meet the requisite manufacturing quality standards and comply to importexport requirements
Challenges faced by manufacturers in product development partnerships which might lead to delay in product launch
bull Stability Studies
bull GMP Inspections
bull Labelling
bull Packaging
bull In country QC testing
bull National Regulatory Authority Approval
bull Reference product selection
Regulatory Approval Processes- Challenges and Implications
The lack of visibility of regulatory requirements can result in higher costs and patientsrsquo delayed access to drugs
$15 million
7
The importance of CMC activities - By the numbers
8
bull Lack of CMC understanding for markets of interest can
bull Discourage companies from pursuing new markets
bull Lead to investing significant time and money in pursuing projects that are not a good fit
bull Lock companies into suboptimal partnerships
bull Increase the cost of market entry
bull Without proper understanding of CMC requirements companies risk spending significant amounts of money on unnecessary (or incorrect) testing and transportation options
bull Delay market entry
bull Potentially lead to product rejections on the border after approval
In the Generics Industry Speed and Efficiency Are Paramount
There is a definitive need to make sure that you have access to the highest quality and most up to date CMC information to avoid submission delays and successfully bring a drug to market to avoid extended timelines unplanned costs and loss of forecasted revenue
9
Common Challenges for CMC Professionals
bull Efficiently track CMC requirements in countries of interest to ensure compliance with evolving regulations
bull Select countries that best fit your capabilities by understanding specific regional requirements for manufacturing trials or distribution
bull Choose the optimal path to market by pinpointing potential approval pathways
bull Develop CMC strategies to balance cost time and quality risk
bull Fully understand requirements around testing and manufacturing before making decisions around who to partner with
Cortellis CMC Intelligence
Donrsquot let lack of regulatory intelligence get in the way of your success
10
ComplianceEfficiently track CMC requirements in countries of interest to ensure compliance with evolving regulations
bull Access country-specific reports comprising of
bull Key Requirementsbull Procedural and administrative requirementsbull Drug substance amp Drug Product CMC
requirementsbull Procedure Visualizationsbull Registration Pathways
11
Country SelectionSelect countries that best fit your capabilities by understanding specific regional requirements for manufacturing trials or distribution
bull Visually compare detailed national regulatory authority-derived Official Regulations and local expertise-based Local Practices
bull Refine results by applying indexing such as product type and pharmaceutical form to target requirements specific to your drugs
12
Regulatory StrategyChoose the optimal path to market by pinpointing potential approval pathways
bull Access detailed workflows for regulatory submission procedures
bull Understand details on accelerated procedures regulatory authority involvement and WHO prequalification
13
Regulatory StrategyDevelop CMC strategies to balance cost time and quality risk
bull Compare CMC requirements across countries to understand differences in official and local requirements and understand which country would fit best with your business
bull Understand detailed requirements to better develop your CMC strategy
14
Partner SelectionFully understand requirements around testing and manufacturing before making decisions around who to partner with
bull Understand official regulations and local practices of potential partner company locations
bull Compare requirements across countries to choose ideal partner based on their capabilities and your strategy
Use Cases
16
❶
❷
❸
❶
bull Select multiple countries of interestbull Drill down appropriate requirements view
Compare Detailed Requirementsbull Select specific ICH eCTD requirements bull Compare detailed national regulatory authority-derived Official Regulations and local expertise-based Local Practicesbull Refine results by applying indexing such as product type and pharmaceutical form
❹
❹
❸
View Reportsbull View country-specific reports comprising
bull Key Factsbull Key Requirementsbull Procedure Visualizationsbull Detailed Requirementsbull Sources
❷ Compare Summary Requirementsbull Select requirements based on the ICH eCTDbull Use visual comparisons to identify differences in requirements across selected countries
Cortellis CMC Intelligence Workflow
17
Use Case 01 ndash Registering a new product in a single country
A pharmaceutical client is registering a new product in Brazil and is
contracting the final release and packaging to a local manufacturer
What documents does the local packager need to provide to us for our submission
How a manufacturer protects and packages their product must be demonstrated by sufficient documentation and
testing of said materials
View Report ndash Detailed Requirements
Brazil selected
View Report active
18Use Case 02 ndash Registering a new product in multiple countries
A pharmaceutical client is registering a new product in Brazil Colombia
and Peru and is contracting the final release and packaging to a local
manufacturer
What documents does the local packager need to provide to us for our
submission
What differences in requirements are there across the targeted countries
How a manufacturer protects and packages their product must be demonstrated by sufficient documentation and
testing of said materials
Compare Detailed Requirements
Multiple countriesselected
View Compare Detailed Requirements active
19Use Case 03 ndash Flagging high level differences in requirements across in
multiple countries
A pharmaceutical client is registering a new product in Brazil
Colombia and Peru and is contracting the final release and
packaging to a local manufacturer
What high level differences in requirements are there across the targeted countries
Compare Summary Requirements
Multiple countriesselected
View Compare Summary Requirements active
20
Your partner for the entire innovation journey
Discovery amp Translational Science
Setting the RampD Direction
Regulatory Compliance
Clinical Trials
Business Development amp Licensing Sourcing amp
Manufacturing
IP Protection
Life Science Solutions
Dr Mandakini Goel|Sr Solution Consultant|MandakinigoelClarivatecom| Clarivatecom
2
Featured Speaker
Dr Mandakini Goel
Sr Solution Consultant South Asia
Clarivate Analytics
3
Agenda
4
6
7
8
15
1 Health for Allhellip
2 Regulatory Approval Processes- Challenges and Implications
3 Why CMC
4 Common Challenges for CMC professionals-Deep Dive
5 Use Cases
4
Sustainable Development Goal 38 of the United Nations-promotion of health through expanded access to quality assured medicines
Health for Allhellip
Manufacturing controls amp Quality assurance systems are the foundation for assuring quality products
Challenge is the easy access of up-to-date manufacturing control requirements- LMIC countries
- Lower and middle income countries
5
Global burden of diseases-
bull Malaria ndash 90 of the cases were in the WHO African Region followed by the WHO South-East Asia Region (7) and the WHO Eastern Mediterranean Region (2) Of the 91 countries reporting indigenous malaria cases in 2016 15 countries ndash all in sub-Saharan Africa except India ndash carried 80 of the global malaria burden
bull Tuberculosis- 86 million new cases
bull HIV- 80 of people living with HIV
Regulatory Challenges-
bull Navigation of regulatory requirements
bull Location and Interpretation of CMC requirements
bull Variations in regional requirements
bull Varying levels of regulatory enforcement maturity
bull Lack of awareness
Why LMICs
6
Many manufacturersrsquo use regulatory programmes such as WHO Prequalification Programme (PQ) and USFDArsquos PEPFAR tentative approval pathway However individual countryrsquos approval through National Regulatory Authority might be required to launch the drugs in country of interest to ensure that the products entering these markets are safe efficacious and meet the requisite manufacturing quality standards and comply to importexport requirements
Challenges faced by manufacturers in product development partnerships which might lead to delay in product launch
bull Stability Studies
bull GMP Inspections
bull Labelling
bull Packaging
bull In country QC testing
bull National Regulatory Authority Approval
bull Reference product selection
Regulatory Approval Processes- Challenges and Implications
The lack of visibility of regulatory requirements can result in higher costs and patientsrsquo delayed access to drugs
$15 million
7
The importance of CMC activities - By the numbers
8
bull Lack of CMC understanding for markets of interest can
bull Discourage companies from pursuing new markets
bull Lead to investing significant time and money in pursuing projects that are not a good fit
bull Lock companies into suboptimal partnerships
bull Increase the cost of market entry
bull Without proper understanding of CMC requirements companies risk spending significant amounts of money on unnecessary (or incorrect) testing and transportation options
bull Delay market entry
bull Potentially lead to product rejections on the border after approval
In the Generics Industry Speed and Efficiency Are Paramount
There is a definitive need to make sure that you have access to the highest quality and most up to date CMC information to avoid submission delays and successfully bring a drug to market to avoid extended timelines unplanned costs and loss of forecasted revenue
9
Common Challenges for CMC Professionals
bull Efficiently track CMC requirements in countries of interest to ensure compliance with evolving regulations
bull Select countries that best fit your capabilities by understanding specific regional requirements for manufacturing trials or distribution
bull Choose the optimal path to market by pinpointing potential approval pathways
bull Develop CMC strategies to balance cost time and quality risk
bull Fully understand requirements around testing and manufacturing before making decisions around who to partner with
Cortellis CMC Intelligence
Donrsquot let lack of regulatory intelligence get in the way of your success
10
ComplianceEfficiently track CMC requirements in countries of interest to ensure compliance with evolving regulations
bull Access country-specific reports comprising of
bull Key Requirementsbull Procedural and administrative requirementsbull Drug substance amp Drug Product CMC
requirementsbull Procedure Visualizationsbull Registration Pathways
11
Country SelectionSelect countries that best fit your capabilities by understanding specific regional requirements for manufacturing trials or distribution
bull Visually compare detailed national regulatory authority-derived Official Regulations and local expertise-based Local Practices
bull Refine results by applying indexing such as product type and pharmaceutical form to target requirements specific to your drugs
12
Regulatory StrategyChoose the optimal path to market by pinpointing potential approval pathways
bull Access detailed workflows for regulatory submission procedures
bull Understand details on accelerated procedures regulatory authority involvement and WHO prequalification
13
Regulatory StrategyDevelop CMC strategies to balance cost time and quality risk
bull Compare CMC requirements across countries to understand differences in official and local requirements and understand which country would fit best with your business
bull Understand detailed requirements to better develop your CMC strategy
14
Partner SelectionFully understand requirements around testing and manufacturing before making decisions around who to partner with
bull Understand official regulations and local practices of potential partner company locations
bull Compare requirements across countries to choose ideal partner based on their capabilities and your strategy
Use Cases
16
❶
❷
❸
❶
bull Select multiple countries of interestbull Drill down appropriate requirements view
Compare Detailed Requirementsbull Select specific ICH eCTD requirements bull Compare detailed national regulatory authority-derived Official Regulations and local expertise-based Local Practicesbull Refine results by applying indexing such as product type and pharmaceutical form
❹
❹
❸
View Reportsbull View country-specific reports comprising
bull Key Factsbull Key Requirementsbull Procedure Visualizationsbull Detailed Requirementsbull Sources
❷ Compare Summary Requirementsbull Select requirements based on the ICH eCTDbull Use visual comparisons to identify differences in requirements across selected countries
Cortellis CMC Intelligence Workflow
17
Use Case 01 ndash Registering a new product in a single country
A pharmaceutical client is registering a new product in Brazil and is
contracting the final release and packaging to a local manufacturer
What documents does the local packager need to provide to us for our submission
How a manufacturer protects and packages their product must be demonstrated by sufficient documentation and
testing of said materials
View Report ndash Detailed Requirements
Brazil selected
View Report active
18Use Case 02 ndash Registering a new product in multiple countries
A pharmaceutical client is registering a new product in Brazil Colombia
and Peru and is contracting the final release and packaging to a local
manufacturer
What documents does the local packager need to provide to us for our
submission
What differences in requirements are there across the targeted countries
How a manufacturer protects and packages their product must be demonstrated by sufficient documentation and
testing of said materials
Compare Detailed Requirements
Multiple countriesselected
View Compare Detailed Requirements active
19Use Case 03 ndash Flagging high level differences in requirements across in
multiple countries
A pharmaceutical client is registering a new product in Brazil
Colombia and Peru and is contracting the final release and
packaging to a local manufacturer
What high level differences in requirements are there across the targeted countries
Compare Summary Requirements
Multiple countriesselected
View Compare Summary Requirements active
20
Your partner for the entire innovation journey
Discovery amp Translational Science
Setting the RampD Direction
Regulatory Compliance
Clinical Trials
Business Development amp Licensing Sourcing amp
Manufacturing
IP Protection
Life Science Solutions
Dr Mandakini Goel|Sr Solution Consultant|MandakinigoelClarivatecom| Clarivatecom
3
Agenda
4
6
7
8
15
1 Health for Allhellip
2 Regulatory Approval Processes- Challenges and Implications
3 Why CMC
4 Common Challenges for CMC professionals-Deep Dive
5 Use Cases
4
Sustainable Development Goal 38 of the United Nations-promotion of health through expanded access to quality assured medicines
Health for Allhellip
Manufacturing controls amp Quality assurance systems are the foundation for assuring quality products
Challenge is the easy access of up-to-date manufacturing control requirements- LMIC countries
- Lower and middle income countries
5
Global burden of diseases-
bull Malaria ndash 90 of the cases were in the WHO African Region followed by the WHO South-East Asia Region (7) and the WHO Eastern Mediterranean Region (2) Of the 91 countries reporting indigenous malaria cases in 2016 15 countries ndash all in sub-Saharan Africa except India ndash carried 80 of the global malaria burden
bull Tuberculosis- 86 million new cases
bull HIV- 80 of people living with HIV
Regulatory Challenges-
bull Navigation of regulatory requirements
bull Location and Interpretation of CMC requirements
bull Variations in regional requirements
bull Varying levels of regulatory enforcement maturity
bull Lack of awareness
Why LMICs
6
Many manufacturersrsquo use regulatory programmes such as WHO Prequalification Programme (PQ) and USFDArsquos PEPFAR tentative approval pathway However individual countryrsquos approval through National Regulatory Authority might be required to launch the drugs in country of interest to ensure that the products entering these markets are safe efficacious and meet the requisite manufacturing quality standards and comply to importexport requirements
Challenges faced by manufacturers in product development partnerships which might lead to delay in product launch
bull Stability Studies
bull GMP Inspections
bull Labelling
bull Packaging
bull In country QC testing
bull National Regulatory Authority Approval
bull Reference product selection
Regulatory Approval Processes- Challenges and Implications
The lack of visibility of regulatory requirements can result in higher costs and patientsrsquo delayed access to drugs
$15 million
7
The importance of CMC activities - By the numbers
8
bull Lack of CMC understanding for markets of interest can
bull Discourage companies from pursuing new markets
bull Lead to investing significant time and money in pursuing projects that are not a good fit
bull Lock companies into suboptimal partnerships
bull Increase the cost of market entry
bull Without proper understanding of CMC requirements companies risk spending significant amounts of money on unnecessary (or incorrect) testing and transportation options
bull Delay market entry
bull Potentially lead to product rejections on the border after approval
In the Generics Industry Speed and Efficiency Are Paramount
There is a definitive need to make sure that you have access to the highest quality and most up to date CMC information to avoid submission delays and successfully bring a drug to market to avoid extended timelines unplanned costs and loss of forecasted revenue
9
Common Challenges for CMC Professionals
bull Efficiently track CMC requirements in countries of interest to ensure compliance with evolving regulations
bull Select countries that best fit your capabilities by understanding specific regional requirements for manufacturing trials or distribution
bull Choose the optimal path to market by pinpointing potential approval pathways
bull Develop CMC strategies to balance cost time and quality risk
bull Fully understand requirements around testing and manufacturing before making decisions around who to partner with
Cortellis CMC Intelligence
Donrsquot let lack of regulatory intelligence get in the way of your success
10
ComplianceEfficiently track CMC requirements in countries of interest to ensure compliance with evolving regulations
bull Access country-specific reports comprising of
bull Key Requirementsbull Procedural and administrative requirementsbull Drug substance amp Drug Product CMC
requirementsbull Procedure Visualizationsbull Registration Pathways
11
Country SelectionSelect countries that best fit your capabilities by understanding specific regional requirements for manufacturing trials or distribution
bull Visually compare detailed national regulatory authority-derived Official Regulations and local expertise-based Local Practices
bull Refine results by applying indexing such as product type and pharmaceutical form to target requirements specific to your drugs
12
Regulatory StrategyChoose the optimal path to market by pinpointing potential approval pathways
bull Access detailed workflows for regulatory submission procedures
bull Understand details on accelerated procedures regulatory authority involvement and WHO prequalification
13
Regulatory StrategyDevelop CMC strategies to balance cost time and quality risk
bull Compare CMC requirements across countries to understand differences in official and local requirements and understand which country would fit best with your business
bull Understand detailed requirements to better develop your CMC strategy
14
Partner SelectionFully understand requirements around testing and manufacturing before making decisions around who to partner with
bull Understand official regulations and local practices of potential partner company locations
bull Compare requirements across countries to choose ideal partner based on their capabilities and your strategy
Use Cases
16
❶
❷
❸
❶
bull Select multiple countries of interestbull Drill down appropriate requirements view
Compare Detailed Requirementsbull Select specific ICH eCTD requirements bull Compare detailed national regulatory authority-derived Official Regulations and local expertise-based Local Practicesbull Refine results by applying indexing such as product type and pharmaceutical form
❹
❹
❸
View Reportsbull View country-specific reports comprising
bull Key Factsbull Key Requirementsbull Procedure Visualizationsbull Detailed Requirementsbull Sources
❷ Compare Summary Requirementsbull Select requirements based on the ICH eCTDbull Use visual comparisons to identify differences in requirements across selected countries
Cortellis CMC Intelligence Workflow
17
Use Case 01 ndash Registering a new product in a single country
A pharmaceutical client is registering a new product in Brazil and is
contracting the final release and packaging to a local manufacturer
What documents does the local packager need to provide to us for our submission
How a manufacturer protects and packages their product must be demonstrated by sufficient documentation and
testing of said materials
View Report ndash Detailed Requirements
Brazil selected
View Report active
18Use Case 02 ndash Registering a new product in multiple countries
A pharmaceutical client is registering a new product in Brazil Colombia
and Peru and is contracting the final release and packaging to a local
manufacturer
What documents does the local packager need to provide to us for our
submission
What differences in requirements are there across the targeted countries
How a manufacturer protects and packages their product must be demonstrated by sufficient documentation and
testing of said materials
Compare Detailed Requirements
Multiple countriesselected
View Compare Detailed Requirements active
19Use Case 03 ndash Flagging high level differences in requirements across in
multiple countries
A pharmaceutical client is registering a new product in Brazil
Colombia and Peru and is contracting the final release and
packaging to a local manufacturer
What high level differences in requirements are there across the targeted countries
Compare Summary Requirements
Multiple countriesselected
View Compare Summary Requirements active
20
Your partner for the entire innovation journey
Discovery amp Translational Science
Setting the RampD Direction
Regulatory Compliance
Clinical Trials
Business Development amp Licensing Sourcing amp
Manufacturing
IP Protection
Life Science Solutions
Dr Mandakini Goel|Sr Solution Consultant|MandakinigoelClarivatecom| Clarivatecom
4
Sustainable Development Goal 38 of the United Nations-promotion of health through expanded access to quality assured medicines
Health for Allhellip
Manufacturing controls amp Quality assurance systems are the foundation for assuring quality products
Challenge is the easy access of up-to-date manufacturing control requirements- LMIC countries
- Lower and middle income countries
5
Global burden of diseases-
bull Malaria ndash 90 of the cases were in the WHO African Region followed by the WHO South-East Asia Region (7) and the WHO Eastern Mediterranean Region (2) Of the 91 countries reporting indigenous malaria cases in 2016 15 countries ndash all in sub-Saharan Africa except India ndash carried 80 of the global malaria burden
bull Tuberculosis- 86 million new cases
bull HIV- 80 of people living with HIV
Regulatory Challenges-
bull Navigation of regulatory requirements
bull Location and Interpretation of CMC requirements
bull Variations in regional requirements
bull Varying levels of regulatory enforcement maturity
bull Lack of awareness
Why LMICs
6
Many manufacturersrsquo use regulatory programmes such as WHO Prequalification Programme (PQ) and USFDArsquos PEPFAR tentative approval pathway However individual countryrsquos approval through National Regulatory Authority might be required to launch the drugs in country of interest to ensure that the products entering these markets are safe efficacious and meet the requisite manufacturing quality standards and comply to importexport requirements
Challenges faced by manufacturers in product development partnerships which might lead to delay in product launch
bull Stability Studies
bull GMP Inspections
bull Labelling
bull Packaging
bull In country QC testing
bull National Regulatory Authority Approval
bull Reference product selection
Regulatory Approval Processes- Challenges and Implications
The lack of visibility of regulatory requirements can result in higher costs and patientsrsquo delayed access to drugs
$15 million
7
The importance of CMC activities - By the numbers
8
bull Lack of CMC understanding for markets of interest can
bull Discourage companies from pursuing new markets
bull Lead to investing significant time and money in pursuing projects that are not a good fit
bull Lock companies into suboptimal partnerships
bull Increase the cost of market entry
bull Without proper understanding of CMC requirements companies risk spending significant amounts of money on unnecessary (or incorrect) testing and transportation options
bull Delay market entry
bull Potentially lead to product rejections on the border after approval
In the Generics Industry Speed and Efficiency Are Paramount
There is a definitive need to make sure that you have access to the highest quality and most up to date CMC information to avoid submission delays and successfully bring a drug to market to avoid extended timelines unplanned costs and loss of forecasted revenue
9
Common Challenges for CMC Professionals
bull Efficiently track CMC requirements in countries of interest to ensure compliance with evolving regulations
bull Select countries that best fit your capabilities by understanding specific regional requirements for manufacturing trials or distribution
bull Choose the optimal path to market by pinpointing potential approval pathways
bull Develop CMC strategies to balance cost time and quality risk
bull Fully understand requirements around testing and manufacturing before making decisions around who to partner with
Cortellis CMC Intelligence
Donrsquot let lack of regulatory intelligence get in the way of your success
10
ComplianceEfficiently track CMC requirements in countries of interest to ensure compliance with evolving regulations
bull Access country-specific reports comprising of
bull Key Requirementsbull Procedural and administrative requirementsbull Drug substance amp Drug Product CMC
requirementsbull Procedure Visualizationsbull Registration Pathways
11
Country SelectionSelect countries that best fit your capabilities by understanding specific regional requirements for manufacturing trials or distribution
bull Visually compare detailed national regulatory authority-derived Official Regulations and local expertise-based Local Practices
bull Refine results by applying indexing such as product type and pharmaceutical form to target requirements specific to your drugs
12
Regulatory StrategyChoose the optimal path to market by pinpointing potential approval pathways
bull Access detailed workflows for regulatory submission procedures
bull Understand details on accelerated procedures regulatory authority involvement and WHO prequalification
13
Regulatory StrategyDevelop CMC strategies to balance cost time and quality risk
bull Compare CMC requirements across countries to understand differences in official and local requirements and understand which country would fit best with your business
bull Understand detailed requirements to better develop your CMC strategy
14
Partner SelectionFully understand requirements around testing and manufacturing before making decisions around who to partner with
bull Understand official regulations and local practices of potential partner company locations
bull Compare requirements across countries to choose ideal partner based on their capabilities and your strategy
Use Cases
16
❶
❷
❸
❶
bull Select multiple countries of interestbull Drill down appropriate requirements view
Compare Detailed Requirementsbull Select specific ICH eCTD requirements bull Compare detailed national regulatory authority-derived Official Regulations and local expertise-based Local Practicesbull Refine results by applying indexing such as product type and pharmaceutical form
❹
❹
❸
View Reportsbull View country-specific reports comprising
bull Key Factsbull Key Requirementsbull Procedure Visualizationsbull Detailed Requirementsbull Sources
❷ Compare Summary Requirementsbull Select requirements based on the ICH eCTDbull Use visual comparisons to identify differences in requirements across selected countries
Cortellis CMC Intelligence Workflow
17
Use Case 01 ndash Registering a new product in a single country
A pharmaceutical client is registering a new product in Brazil and is
contracting the final release and packaging to a local manufacturer
What documents does the local packager need to provide to us for our submission
How a manufacturer protects and packages their product must be demonstrated by sufficient documentation and
testing of said materials
View Report ndash Detailed Requirements
Brazil selected
View Report active
18Use Case 02 ndash Registering a new product in multiple countries
A pharmaceutical client is registering a new product in Brazil Colombia
and Peru and is contracting the final release and packaging to a local
manufacturer
What documents does the local packager need to provide to us for our
submission
What differences in requirements are there across the targeted countries
How a manufacturer protects and packages their product must be demonstrated by sufficient documentation and
testing of said materials
Compare Detailed Requirements
Multiple countriesselected
View Compare Detailed Requirements active
19Use Case 03 ndash Flagging high level differences in requirements across in
multiple countries
A pharmaceutical client is registering a new product in Brazil
Colombia and Peru and is contracting the final release and
packaging to a local manufacturer
What high level differences in requirements are there across the targeted countries
Compare Summary Requirements
Multiple countriesselected
View Compare Summary Requirements active
20
Your partner for the entire innovation journey
Discovery amp Translational Science
Setting the RampD Direction
Regulatory Compliance
Clinical Trials
Business Development amp Licensing Sourcing amp
Manufacturing
IP Protection
Life Science Solutions
Dr Mandakini Goel|Sr Solution Consultant|MandakinigoelClarivatecom| Clarivatecom
5
Global burden of diseases-
bull Malaria ndash 90 of the cases were in the WHO African Region followed by the WHO South-East Asia Region (7) and the WHO Eastern Mediterranean Region (2) Of the 91 countries reporting indigenous malaria cases in 2016 15 countries ndash all in sub-Saharan Africa except India ndash carried 80 of the global malaria burden
bull Tuberculosis- 86 million new cases
bull HIV- 80 of people living with HIV
Regulatory Challenges-
bull Navigation of regulatory requirements
bull Location and Interpretation of CMC requirements
bull Variations in regional requirements
bull Varying levels of regulatory enforcement maturity
bull Lack of awareness
Why LMICs
6
Many manufacturersrsquo use regulatory programmes such as WHO Prequalification Programme (PQ) and USFDArsquos PEPFAR tentative approval pathway However individual countryrsquos approval through National Regulatory Authority might be required to launch the drugs in country of interest to ensure that the products entering these markets are safe efficacious and meet the requisite manufacturing quality standards and comply to importexport requirements
Challenges faced by manufacturers in product development partnerships which might lead to delay in product launch
bull Stability Studies
bull GMP Inspections
bull Labelling
bull Packaging
bull In country QC testing
bull National Regulatory Authority Approval
bull Reference product selection
Regulatory Approval Processes- Challenges and Implications
The lack of visibility of regulatory requirements can result in higher costs and patientsrsquo delayed access to drugs
$15 million
7
The importance of CMC activities - By the numbers
8
bull Lack of CMC understanding for markets of interest can
bull Discourage companies from pursuing new markets
bull Lead to investing significant time and money in pursuing projects that are not a good fit
bull Lock companies into suboptimal partnerships
bull Increase the cost of market entry
bull Without proper understanding of CMC requirements companies risk spending significant amounts of money on unnecessary (or incorrect) testing and transportation options
bull Delay market entry
bull Potentially lead to product rejections on the border after approval
In the Generics Industry Speed and Efficiency Are Paramount
There is a definitive need to make sure that you have access to the highest quality and most up to date CMC information to avoid submission delays and successfully bring a drug to market to avoid extended timelines unplanned costs and loss of forecasted revenue
9
Common Challenges for CMC Professionals
bull Efficiently track CMC requirements in countries of interest to ensure compliance with evolving regulations
bull Select countries that best fit your capabilities by understanding specific regional requirements for manufacturing trials or distribution
bull Choose the optimal path to market by pinpointing potential approval pathways
bull Develop CMC strategies to balance cost time and quality risk
bull Fully understand requirements around testing and manufacturing before making decisions around who to partner with
Cortellis CMC Intelligence
Donrsquot let lack of regulatory intelligence get in the way of your success
10
ComplianceEfficiently track CMC requirements in countries of interest to ensure compliance with evolving regulations
bull Access country-specific reports comprising of
bull Key Requirementsbull Procedural and administrative requirementsbull Drug substance amp Drug Product CMC
requirementsbull Procedure Visualizationsbull Registration Pathways
11
Country SelectionSelect countries that best fit your capabilities by understanding specific regional requirements for manufacturing trials or distribution
bull Visually compare detailed national regulatory authority-derived Official Regulations and local expertise-based Local Practices
bull Refine results by applying indexing such as product type and pharmaceutical form to target requirements specific to your drugs
12
Regulatory StrategyChoose the optimal path to market by pinpointing potential approval pathways
bull Access detailed workflows for regulatory submission procedures
bull Understand details on accelerated procedures regulatory authority involvement and WHO prequalification
13
Regulatory StrategyDevelop CMC strategies to balance cost time and quality risk
bull Compare CMC requirements across countries to understand differences in official and local requirements and understand which country would fit best with your business
bull Understand detailed requirements to better develop your CMC strategy
14
Partner SelectionFully understand requirements around testing and manufacturing before making decisions around who to partner with
bull Understand official regulations and local practices of potential partner company locations
bull Compare requirements across countries to choose ideal partner based on their capabilities and your strategy
Use Cases
16
❶
❷
❸
❶
bull Select multiple countries of interestbull Drill down appropriate requirements view
Compare Detailed Requirementsbull Select specific ICH eCTD requirements bull Compare detailed national regulatory authority-derived Official Regulations and local expertise-based Local Practicesbull Refine results by applying indexing such as product type and pharmaceutical form
❹
❹
❸
View Reportsbull View country-specific reports comprising
bull Key Factsbull Key Requirementsbull Procedure Visualizationsbull Detailed Requirementsbull Sources
❷ Compare Summary Requirementsbull Select requirements based on the ICH eCTDbull Use visual comparisons to identify differences in requirements across selected countries
Cortellis CMC Intelligence Workflow
17
Use Case 01 ndash Registering a new product in a single country
A pharmaceutical client is registering a new product in Brazil and is
contracting the final release and packaging to a local manufacturer
What documents does the local packager need to provide to us for our submission
How a manufacturer protects and packages their product must be demonstrated by sufficient documentation and
testing of said materials
View Report ndash Detailed Requirements
Brazil selected
View Report active
18Use Case 02 ndash Registering a new product in multiple countries
A pharmaceutical client is registering a new product in Brazil Colombia
and Peru and is contracting the final release and packaging to a local
manufacturer
What documents does the local packager need to provide to us for our
submission
What differences in requirements are there across the targeted countries
How a manufacturer protects and packages their product must be demonstrated by sufficient documentation and
testing of said materials
Compare Detailed Requirements
Multiple countriesselected
View Compare Detailed Requirements active
19Use Case 03 ndash Flagging high level differences in requirements across in
multiple countries
A pharmaceutical client is registering a new product in Brazil
Colombia and Peru and is contracting the final release and
packaging to a local manufacturer
What high level differences in requirements are there across the targeted countries
Compare Summary Requirements
Multiple countriesselected
View Compare Summary Requirements active
20
Your partner for the entire innovation journey
Discovery amp Translational Science
Setting the RampD Direction
Regulatory Compliance
Clinical Trials
Business Development amp Licensing Sourcing amp
Manufacturing
IP Protection
Life Science Solutions
Dr Mandakini Goel|Sr Solution Consultant|MandakinigoelClarivatecom| Clarivatecom
6
Many manufacturersrsquo use regulatory programmes such as WHO Prequalification Programme (PQ) and USFDArsquos PEPFAR tentative approval pathway However individual countryrsquos approval through National Regulatory Authority might be required to launch the drugs in country of interest to ensure that the products entering these markets are safe efficacious and meet the requisite manufacturing quality standards and comply to importexport requirements
Challenges faced by manufacturers in product development partnerships which might lead to delay in product launch
bull Stability Studies
bull GMP Inspections
bull Labelling
bull Packaging
bull In country QC testing
bull National Regulatory Authority Approval
bull Reference product selection
Regulatory Approval Processes- Challenges and Implications
The lack of visibility of regulatory requirements can result in higher costs and patientsrsquo delayed access to drugs
$15 million
7
The importance of CMC activities - By the numbers
8
bull Lack of CMC understanding for markets of interest can
bull Discourage companies from pursuing new markets
bull Lead to investing significant time and money in pursuing projects that are not a good fit
bull Lock companies into suboptimal partnerships
bull Increase the cost of market entry
bull Without proper understanding of CMC requirements companies risk spending significant amounts of money on unnecessary (or incorrect) testing and transportation options
bull Delay market entry
bull Potentially lead to product rejections on the border after approval
In the Generics Industry Speed and Efficiency Are Paramount
There is a definitive need to make sure that you have access to the highest quality and most up to date CMC information to avoid submission delays and successfully bring a drug to market to avoid extended timelines unplanned costs and loss of forecasted revenue
9
Common Challenges for CMC Professionals
bull Efficiently track CMC requirements in countries of interest to ensure compliance with evolving regulations
bull Select countries that best fit your capabilities by understanding specific regional requirements for manufacturing trials or distribution
bull Choose the optimal path to market by pinpointing potential approval pathways
bull Develop CMC strategies to balance cost time and quality risk
bull Fully understand requirements around testing and manufacturing before making decisions around who to partner with
Cortellis CMC Intelligence
Donrsquot let lack of regulatory intelligence get in the way of your success
10
ComplianceEfficiently track CMC requirements in countries of interest to ensure compliance with evolving regulations
bull Access country-specific reports comprising of
bull Key Requirementsbull Procedural and administrative requirementsbull Drug substance amp Drug Product CMC
requirementsbull Procedure Visualizationsbull Registration Pathways
11
Country SelectionSelect countries that best fit your capabilities by understanding specific regional requirements for manufacturing trials or distribution
bull Visually compare detailed national regulatory authority-derived Official Regulations and local expertise-based Local Practices
bull Refine results by applying indexing such as product type and pharmaceutical form to target requirements specific to your drugs
12
Regulatory StrategyChoose the optimal path to market by pinpointing potential approval pathways
bull Access detailed workflows for regulatory submission procedures
bull Understand details on accelerated procedures regulatory authority involvement and WHO prequalification
13
Regulatory StrategyDevelop CMC strategies to balance cost time and quality risk
bull Compare CMC requirements across countries to understand differences in official and local requirements and understand which country would fit best with your business
bull Understand detailed requirements to better develop your CMC strategy
14
Partner SelectionFully understand requirements around testing and manufacturing before making decisions around who to partner with
bull Understand official regulations and local practices of potential partner company locations
bull Compare requirements across countries to choose ideal partner based on their capabilities and your strategy
Use Cases
16
❶
❷
❸
❶
bull Select multiple countries of interestbull Drill down appropriate requirements view
Compare Detailed Requirementsbull Select specific ICH eCTD requirements bull Compare detailed national regulatory authority-derived Official Regulations and local expertise-based Local Practicesbull Refine results by applying indexing such as product type and pharmaceutical form
❹
❹
❸
View Reportsbull View country-specific reports comprising
bull Key Factsbull Key Requirementsbull Procedure Visualizationsbull Detailed Requirementsbull Sources
❷ Compare Summary Requirementsbull Select requirements based on the ICH eCTDbull Use visual comparisons to identify differences in requirements across selected countries
Cortellis CMC Intelligence Workflow
17
Use Case 01 ndash Registering a new product in a single country
A pharmaceutical client is registering a new product in Brazil and is
contracting the final release and packaging to a local manufacturer
What documents does the local packager need to provide to us for our submission
How a manufacturer protects and packages their product must be demonstrated by sufficient documentation and
testing of said materials
View Report ndash Detailed Requirements
Brazil selected
View Report active
18Use Case 02 ndash Registering a new product in multiple countries
A pharmaceutical client is registering a new product in Brazil Colombia
and Peru and is contracting the final release and packaging to a local
manufacturer
What documents does the local packager need to provide to us for our
submission
What differences in requirements are there across the targeted countries
How a manufacturer protects and packages their product must be demonstrated by sufficient documentation and
testing of said materials
Compare Detailed Requirements
Multiple countriesselected
View Compare Detailed Requirements active
19Use Case 03 ndash Flagging high level differences in requirements across in
multiple countries
A pharmaceutical client is registering a new product in Brazil
Colombia and Peru and is contracting the final release and
packaging to a local manufacturer
What high level differences in requirements are there across the targeted countries
Compare Summary Requirements
Multiple countriesselected
View Compare Summary Requirements active
20
Your partner for the entire innovation journey
Discovery amp Translational Science
Setting the RampD Direction
Regulatory Compliance
Clinical Trials
Business Development amp Licensing Sourcing amp
Manufacturing
IP Protection
Life Science Solutions
Dr Mandakini Goel|Sr Solution Consultant|MandakinigoelClarivatecom| Clarivatecom
7
The importance of CMC activities - By the numbers
8
bull Lack of CMC understanding for markets of interest can
bull Discourage companies from pursuing new markets
bull Lead to investing significant time and money in pursuing projects that are not a good fit
bull Lock companies into suboptimal partnerships
bull Increase the cost of market entry
bull Without proper understanding of CMC requirements companies risk spending significant amounts of money on unnecessary (or incorrect) testing and transportation options
bull Delay market entry
bull Potentially lead to product rejections on the border after approval
In the Generics Industry Speed and Efficiency Are Paramount
There is a definitive need to make sure that you have access to the highest quality and most up to date CMC information to avoid submission delays and successfully bring a drug to market to avoid extended timelines unplanned costs and loss of forecasted revenue
9
Common Challenges for CMC Professionals
bull Efficiently track CMC requirements in countries of interest to ensure compliance with evolving regulations
bull Select countries that best fit your capabilities by understanding specific regional requirements for manufacturing trials or distribution
bull Choose the optimal path to market by pinpointing potential approval pathways
bull Develop CMC strategies to balance cost time and quality risk
bull Fully understand requirements around testing and manufacturing before making decisions around who to partner with
Cortellis CMC Intelligence
Donrsquot let lack of regulatory intelligence get in the way of your success
10
ComplianceEfficiently track CMC requirements in countries of interest to ensure compliance with evolving regulations
bull Access country-specific reports comprising of
bull Key Requirementsbull Procedural and administrative requirementsbull Drug substance amp Drug Product CMC
requirementsbull Procedure Visualizationsbull Registration Pathways
11
Country SelectionSelect countries that best fit your capabilities by understanding specific regional requirements for manufacturing trials or distribution
bull Visually compare detailed national regulatory authority-derived Official Regulations and local expertise-based Local Practices
bull Refine results by applying indexing such as product type and pharmaceutical form to target requirements specific to your drugs
12
Regulatory StrategyChoose the optimal path to market by pinpointing potential approval pathways
bull Access detailed workflows for regulatory submission procedures
bull Understand details on accelerated procedures regulatory authority involvement and WHO prequalification
13
Regulatory StrategyDevelop CMC strategies to balance cost time and quality risk
bull Compare CMC requirements across countries to understand differences in official and local requirements and understand which country would fit best with your business
bull Understand detailed requirements to better develop your CMC strategy
14
Partner SelectionFully understand requirements around testing and manufacturing before making decisions around who to partner with
bull Understand official regulations and local practices of potential partner company locations
bull Compare requirements across countries to choose ideal partner based on their capabilities and your strategy
Use Cases
16
❶
❷
❸
❶
bull Select multiple countries of interestbull Drill down appropriate requirements view
Compare Detailed Requirementsbull Select specific ICH eCTD requirements bull Compare detailed national regulatory authority-derived Official Regulations and local expertise-based Local Practicesbull Refine results by applying indexing such as product type and pharmaceutical form
❹
❹
❸
View Reportsbull View country-specific reports comprising
bull Key Factsbull Key Requirementsbull Procedure Visualizationsbull Detailed Requirementsbull Sources
❷ Compare Summary Requirementsbull Select requirements based on the ICH eCTDbull Use visual comparisons to identify differences in requirements across selected countries
Cortellis CMC Intelligence Workflow
17
Use Case 01 ndash Registering a new product in a single country
A pharmaceutical client is registering a new product in Brazil and is
contracting the final release and packaging to a local manufacturer
What documents does the local packager need to provide to us for our submission
How a manufacturer protects and packages their product must be demonstrated by sufficient documentation and
testing of said materials
View Report ndash Detailed Requirements
Brazil selected
View Report active
18Use Case 02 ndash Registering a new product in multiple countries
A pharmaceutical client is registering a new product in Brazil Colombia
and Peru and is contracting the final release and packaging to a local
manufacturer
What documents does the local packager need to provide to us for our
submission
What differences in requirements are there across the targeted countries
How a manufacturer protects and packages their product must be demonstrated by sufficient documentation and
testing of said materials
Compare Detailed Requirements
Multiple countriesselected
View Compare Detailed Requirements active
19Use Case 03 ndash Flagging high level differences in requirements across in
multiple countries
A pharmaceutical client is registering a new product in Brazil
Colombia and Peru and is contracting the final release and
packaging to a local manufacturer
What high level differences in requirements are there across the targeted countries
Compare Summary Requirements
Multiple countriesselected
View Compare Summary Requirements active
20
Your partner for the entire innovation journey
Discovery amp Translational Science
Setting the RampD Direction
Regulatory Compliance
Clinical Trials
Business Development amp Licensing Sourcing amp
Manufacturing
IP Protection
Life Science Solutions
Dr Mandakini Goel|Sr Solution Consultant|MandakinigoelClarivatecom| Clarivatecom
8
bull Lack of CMC understanding for markets of interest can
bull Discourage companies from pursuing new markets
bull Lead to investing significant time and money in pursuing projects that are not a good fit
bull Lock companies into suboptimal partnerships
bull Increase the cost of market entry
bull Without proper understanding of CMC requirements companies risk spending significant amounts of money on unnecessary (or incorrect) testing and transportation options
bull Delay market entry
bull Potentially lead to product rejections on the border after approval
In the Generics Industry Speed and Efficiency Are Paramount
There is a definitive need to make sure that you have access to the highest quality and most up to date CMC information to avoid submission delays and successfully bring a drug to market to avoid extended timelines unplanned costs and loss of forecasted revenue
9
Common Challenges for CMC Professionals
bull Efficiently track CMC requirements in countries of interest to ensure compliance with evolving regulations
bull Select countries that best fit your capabilities by understanding specific regional requirements for manufacturing trials or distribution
bull Choose the optimal path to market by pinpointing potential approval pathways
bull Develop CMC strategies to balance cost time and quality risk
bull Fully understand requirements around testing and manufacturing before making decisions around who to partner with
Cortellis CMC Intelligence
Donrsquot let lack of regulatory intelligence get in the way of your success
10
ComplianceEfficiently track CMC requirements in countries of interest to ensure compliance with evolving regulations
bull Access country-specific reports comprising of
bull Key Requirementsbull Procedural and administrative requirementsbull Drug substance amp Drug Product CMC
requirementsbull Procedure Visualizationsbull Registration Pathways
11
Country SelectionSelect countries that best fit your capabilities by understanding specific regional requirements for manufacturing trials or distribution
bull Visually compare detailed national regulatory authority-derived Official Regulations and local expertise-based Local Practices
bull Refine results by applying indexing such as product type and pharmaceutical form to target requirements specific to your drugs
12
Regulatory StrategyChoose the optimal path to market by pinpointing potential approval pathways
bull Access detailed workflows for regulatory submission procedures
bull Understand details on accelerated procedures regulatory authority involvement and WHO prequalification
13
Regulatory StrategyDevelop CMC strategies to balance cost time and quality risk
bull Compare CMC requirements across countries to understand differences in official and local requirements and understand which country would fit best with your business
bull Understand detailed requirements to better develop your CMC strategy
14
Partner SelectionFully understand requirements around testing and manufacturing before making decisions around who to partner with
bull Understand official regulations and local practices of potential partner company locations
bull Compare requirements across countries to choose ideal partner based on their capabilities and your strategy
Use Cases
16
❶
❷
❸
❶
bull Select multiple countries of interestbull Drill down appropriate requirements view
Compare Detailed Requirementsbull Select specific ICH eCTD requirements bull Compare detailed national regulatory authority-derived Official Regulations and local expertise-based Local Practicesbull Refine results by applying indexing such as product type and pharmaceutical form
❹
❹
❸
View Reportsbull View country-specific reports comprising
bull Key Factsbull Key Requirementsbull Procedure Visualizationsbull Detailed Requirementsbull Sources
❷ Compare Summary Requirementsbull Select requirements based on the ICH eCTDbull Use visual comparisons to identify differences in requirements across selected countries
Cortellis CMC Intelligence Workflow
17
Use Case 01 ndash Registering a new product in a single country
A pharmaceutical client is registering a new product in Brazil and is
contracting the final release and packaging to a local manufacturer
What documents does the local packager need to provide to us for our submission
How a manufacturer protects and packages their product must be demonstrated by sufficient documentation and
testing of said materials
View Report ndash Detailed Requirements
Brazil selected
View Report active
18Use Case 02 ndash Registering a new product in multiple countries
A pharmaceutical client is registering a new product in Brazil Colombia
and Peru and is contracting the final release and packaging to a local
manufacturer
What documents does the local packager need to provide to us for our
submission
What differences in requirements are there across the targeted countries
How a manufacturer protects and packages their product must be demonstrated by sufficient documentation and
testing of said materials
Compare Detailed Requirements
Multiple countriesselected
View Compare Detailed Requirements active
19Use Case 03 ndash Flagging high level differences in requirements across in
multiple countries
A pharmaceutical client is registering a new product in Brazil
Colombia and Peru and is contracting the final release and
packaging to a local manufacturer
What high level differences in requirements are there across the targeted countries
Compare Summary Requirements
Multiple countriesselected
View Compare Summary Requirements active
20
Your partner for the entire innovation journey
Discovery amp Translational Science
Setting the RampD Direction
Regulatory Compliance
Clinical Trials
Business Development amp Licensing Sourcing amp
Manufacturing
IP Protection
Life Science Solutions
Dr Mandakini Goel|Sr Solution Consultant|MandakinigoelClarivatecom| Clarivatecom
9
Common Challenges for CMC Professionals
bull Efficiently track CMC requirements in countries of interest to ensure compliance with evolving regulations
bull Select countries that best fit your capabilities by understanding specific regional requirements for manufacturing trials or distribution
bull Choose the optimal path to market by pinpointing potential approval pathways
bull Develop CMC strategies to balance cost time and quality risk
bull Fully understand requirements around testing and manufacturing before making decisions around who to partner with
Cortellis CMC Intelligence
Donrsquot let lack of regulatory intelligence get in the way of your success
10
ComplianceEfficiently track CMC requirements in countries of interest to ensure compliance with evolving regulations
bull Access country-specific reports comprising of
bull Key Requirementsbull Procedural and administrative requirementsbull Drug substance amp Drug Product CMC
requirementsbull Procedure Visualizationsbull Registration Pathways
11
Country SelectionSelect countries that best fit your capabilities by understanding specific regional requirements for manufacturing trials or distribution
bull Visually compare detailed national regulatory authority-derived Official Regulations and local expertise-based Local Practices
bull Refine results by applying indexing such as product type and pharmaceutical form to target requirements specific to your drugs
12
Regulatory StrategyChoose the optimal path to market by pinpointing potential approval pathways
bull Access detailed workflows for regulatory submission procedures
bull Understand details on accelerated procedures regulatory authority involvement and WHO prequalification
13
Regulatory StrategyDevelop CMC strategies to balance cost time and quality risk
bull Compare CMC requirements across countries to understand differences in official and local requirements and understand which country would fit best with your business
bull Understand detailed requirements to better develop your CMC strategy
14
Partner SelectionFully understand requirements around testing and manufacturing before making decisions around who to partner with
bull Understand official regulations and local practices of potential partner company locations
bull Compare requirements across countries to choose ideal partner based on their capabilities and your strategy
Use Cases
16
❶
❷
❸
❶
bull Select multiple countries of interestbull Drill down appropriate requirements view
Compare Detailed Requirementsbull Select specific ICH eCTD requirements bull Compare detailed national regulatory authority-derived Official Regulations and local expertise-based Local Practicesbull Refine results by applying indexing such as product type and pharmaceutical form
❹
❹
❸
View Reportsbull View country-specific reports comprising
bull Key Factsbull Key Requirementsbull Procedure Visualizationsbull Detailed Requirementsbull Sources
❷ Compare Summary Requirementsbull Select requirements based on the ICH eCTDbull Use visual comparisons to identify differences in requirements across selected countries
Cortellis CMC Intelligence Workflow
17
Use Case 01 ndash Registering a new product in a single country
A pharmaceutical client is registering a new product in Brazil and is
contracting the final release and packaging to a local manufacturer
What documents does the local packager need to provide to us for our submission
How a manufacturer protects and packages their product must be demonstrated by sufficient documentation and
testing of said materials
View Report ndash Detailed Requirements
Brazil selected
View Report active
18Use Case 02 ndash Registering a new product in multiple countries
A pharmaceutical client is registering a new product in Brazil Colombia
and Peru and is contracting the final release and packaging to a local
manufacturer
What documents does the local packager need to provide to us for our
submission
What differences in requirements are there across the targeted countries
How a manufacturer protects and packages their product must be demonstrated by sufficient documentation and
testing of said materials
Compare Detailed Requirements
Multiple countriesselected
View Compare Detailed Requirements active
19Use Case 03 ndash Flagging high level differences in requirements across in
multiple countries
A pharmaceutical client is registering a new product in Brazil
Colombia and Peru and is contracting the final release and
packaging to a local manufacturer
What high level differences in requirements are there across the targeted countries
Compare Summary Requirements
Multiple countriesselected
View Compare Summary Requirements active
20
Your partner for the entire innovation journey
Discovery amp Translational Science
Setting the RampD Direction
Regulatory Compliance
Clinical Trials
Business Development amp Licensing Sourcing amp
Manufacturing
IP Protection
Life Science Solutions
Dr Mandakini Goel|Sr Solution Consultant|MandakinigoelClarivatecom| Clarivatecom
10
ComplianceEfficiently track CMC requirements in countries of interest to ensure compliance with evolving regulations
bull Access country-specific reports comprising of
bull Key Requirementsbull Procedural and administrative requirementsbull Drug substance amp Drug Product CMC
requirementsbull Procedure Visualizationsbull Registration Pathways
11
Country SelectionSelect countries that best fit your capabilities by understanding specific regional requirements for manufacturing trials or distribution
bull Visually compare detailed national regulatory authority-derived Official Regulations and local expertise-based Local Practices
bull Refine results by applying indexing such as product type and pharmaceutical form to target requirements specific to your drugs
12
Regulatory StrategyChoose the optimal path to market by pinpointing potential approval pathways
bull Access detailed workflows for regulatory submission procedures
bull Understand details on accelerated procedures regulatory authority involvement and WHO prequalification
13
Regulatory StrategyDevelop CMC strategies to balance cost time and quality risk
bull Compare CMC requirements across countries to understand differences in official and local requirements and understand which country would fit best with your business
bull Understand detailed requirements to better develop your CMC strategy
14
Partner SelectionFully understand requirements around testing and manufacturing before making decisions around who to partner with
bull Understand official regulations and local practices of potential partner company locations
bull Compare requirements across countries to choose ideal partner based on their capabilities and your strategy
Use Cases
16
❶
❷
❸
❶
bull Select multiple countries of interestbull Drill down appropriate requirements view
Compare Detailed Requirementsbull Select specific ICH eCTD requirements bull Compare detailed national regulatory authority-derived Official Regulations and local expertise-based Local Practicesbull Refine results by applying indexing such as product type and pharmaceutical form
❹
❹
❸
View Reportsbull View country-specific reports comprising
bull Key Factsbull Key Requirementsbull Procedure Visualizationsbull Detailed Requirementsbull Sources
❷ Compare Summary Requirementsbull Select requirements based on the ICH eCTDbull Use visual comparisons to identify differences in requirements across selected countries
Cortellis CMC Intelligence Workflow
17
Use Case 01 ndash Registering a new product in a single country
A pharmaceutical client is registering a new product in Brazil and is
contracting the final release and packaging to a local manufacturer
What documents does the local packager need to provide to us for our submission
How a manufacturer protects and packages their product must be demonstrated by sufficient documentation and
testing of said materials
View Report ndash Detailed Requirements
Brazil selected
View Report active
18Use Case 02 ndash Registering a new product in multiple countries
A pharmaceutical client is registering a new product in Brazil Colombia
and Peru and is contracting the final release and packaging to a local
manufacturer
What documents does the local packager need to provide to us for our
submission
What differences in requirements are there across the targeted countries
How a manufacturer protects and packages their product must be demonstrated by sufficient documentation and
testing of said materials
Compare Detailed Requirements
Multiple countriesselected
View Compare Detailed Requirements active
19Use Case 03 ndash Flagging high level differences in requirements across in
multiple countries
A pharmaceutical client is registering a new product in Brazil
Colombia and Peru and is contracting the final release and
packaging to a local manufacturer
What high level differences in requirements are there across the targeted countries
Compare Summary Requirements
Multiple countriesselected
View Compare Summary Requirements active
20
Your partner for the entire innovation journey
Discovery amp Translational Science
Setting the RampD Direction
Regulatory Compliance
Clinical Trials
Business Development amp Licensing Sourcing amp
Manufacturing
IP Protection
Life Science Solutions
Dr Mandakini Goel|Sr Solution Consultant|MandakinigoelClarivatecom| Clarivatecom
11
Country SelectionSelect countries that best fit your capabilities by understanding specific regional requirements for manufacturing trials or distribution
bull Visually compare detailed national regulatory authority-derived Official Regulations and local expertise-based Local Practices
bull Refine results by applying indexing such as product type and pharmaceutical form to target requirements specific to your drugs
12
Regulatory StrategyChoose the optimal path to market by pinpointing potential approval pathways
bull Access detailed workflows for regulatory submission procedures
bull Understand details on accelerated procedures regulatory authority involvement and WHO prequalification
13
Regulatory StrategyDevelop CMC strategies to balance cost time and quality risk
bull Compare CMC requirements across countries to understand differences in official and local requirements and understand which country would fit best with your business
bull Understand detailed requirements to better develop your CMC strategy
14
Partner SelectionFully understand requirements around testing and manufacturing before making decisions around who to partner with
bull Understand official regulations and local practices of potential partner company locations
bull Compare requirements across countries to choose ideal partner based on their capabilities and your strategy
Use Cases
16
❶
❷
❸
❶
bull Select multiple countries of interestbull Drill down appropriate requirements view
Compare Detailed Requirementsbull Select specific ICH eCTD requirements bull Compare detailed national regulatory authority-derived Official Regulations and local expertise-based Local Practicesbull Refine results by applying indexing such as product type and pharmaceutical form
❹
❹
❸
View Reportsbull View country-specific reports comprising
bull Key Factsbull Key Requirementsbull Procedure Visualizationsbull Detailed Requirementsbull Sources
❷ Compare Summary Requirementsbull Select requirements based on the ICH eCTDbull Use visual comparisons to identify differences in requirements across selected countries
Cortellis CMC Intelligence Workflow
17
Use Case 01 ndash Registering a new product in a single country
A pharmaceutical client is registering a new product in Brazil and is
contracting the final release and packaging to a local manufacturer
What documents does the local packager need to provide to us for our submission
How a manufacturer protects and packages their product must be demonstrated by sufficient documentation and
testing of said materials
View Report ndash Detailed Requirements
Brazil selected
View Report active
18Use Case 02 ndash Registering a new product in multiple countries
A pharmaceutical client is registering a new product in Brazil Colombia
and Peru and is contracting the final release and packaging to a local
manufacturer
What documents does the local packager need to provide to us for our
submission
What differences in requirements are there across the targeted countries
How a manufacturer protects and packages their product must be demonstrated by sufficient documentation and
testing of said materials
Compare Detailed Requirements
Multiple countriesselected
View Compare Detailed Requirements active
19Use Case 03 ndash Flagging high level differences in requirements across in
multiple countries
A pharmaceutical client is registering a new product in Brazil
Colombia and Peru and is contracting the final release and
packaging to a local manufacturer
What high level differences in requirements are there across the targeted countries
Compare Summary Requirements
Multiple countriesselected
View Compare Summary Requirements active
20
Your partner for the entire innovation journey
Discovery amp Translational Science
Setting the RampD Direction
Regulatory Compliance
Clinical Trials
Business Development amp Licensing Sourcing amp
Manufacturing
IP Protection
Life Science Solutions
Dr Mandakini Goel|Sr Solution Consultant|MandakinigoelClarivatecom| Clarivatecom
12
Regulatory StrategyChoose the optimal path to market by pinpointing potential approval pathways
bull Access detailed workflows for regulatory submission procedures
bull Understand details on accelerated procedures regulatory authority involvement and WHO prequalification
13
Regulatory StrategyDevelop CMC strategies to balance cost time and quality risk
bull Compare CMC requirements across countries to understand differences in official and local requirements and understand which country would fit best with your business
bull Understand detailed requirements to better develop your CMC strategy
14
Partner SelectionFully understand requirements around testing and manufacturing before making decisions around who to partner with
bull Understand official regulations and local practices of potential partner company locations
bull Compare requirements across countries to choose ideal partner based on their capabilities and your strategy
Use Cases
16
❶
❷
❸
❶
bull Select multiple countries of interestbull Drill down appropriate requirements view
Compare Detailed Requirementsbull Select specific ICH eCTD requirements bull Compare detailed national regulatory authority-derived Official Regulations and local expertise-based Local Practicesbull Refine results by applying indexing such as product type and pharmaceutical form
❹
❹
❸
View Reportsbull View country-specific reports comprising
bull Key Factsbull Key Requirementsbull Procedure Visualizationsbull Detailed Requirementsbull Sources
❷ Compare Summary Requirementsbull Select requirements based on the ICH eCTDbull Use visual comparisons to identify differences in requirements across selected countries
Cortellis CMC Intelligence Workflow
17
Use Case 01 ndash Registering a new product in a single country
A pharmaceutical client is registering a new product in Brazil and is
contracting the final release and packaging to a local manufacturer
What documents does the local packager need to provide to us for our submission
How a manufacturer protects and packages their product must be demonstrated by sufficient documentation and
testing of said materials
View Report ndash Detailed Requirements
Brazil selected
View Report active
18Use Case 02 ndash Registering a new product in multiple countries
A pharmaceutical client is registering a new product in Brazil Colombia
and Peru and is contracting the final release and packaging to a local
manufacturer
What documents does the local packager need to provide to us for our
submission
What differences in requirements are there across the targeted countries
How a manufacturer protects and packages their product must be demonstrated by sufficient documentation and
testing of said materials
Compare Detailed Requirements
Multiple countriesselected
View Compare Detailed Requirements active
19Use Case 03 ndash Flagging high level differences in requirements across in
multiple countries
A pharmaceutical client is registering a new product in Brazil
Colombia and Peru and is contracting the final release and
packaging to a local manufacturer
What high level differences in requirements are there across the targeted countries
Compare Summary Requirements
Multiple countriesselected
View Compare Summary Requirements active
20
Your partner for the entire innovation journey
Discovery amp Translational Science
Setting the RampD Direction
Regulatory Compliance
Clinical Trials
Business Development amp Licensing Sourcing amp
Manufacturing
IP Protection
Life Science Solutions
Dr Mandakini Goel|Sr Solution Consultant|MandakinigoelClarivatecom| Clarivatecom
13
Regulatory StrategyDevelop CMC strategies to balance cost time and quality risk
bull Compare CMC requirements across countries to understand differences in official and local requirements and understand which country would fit best with your business
bull Understand detailed requirements to better develop your CMC strategy
14
Partner SelectionFully understand requirements around testing and manufacturing before making decisions around who to partner with
bull Understand official regulations and local practices of potential partner company locations
bull Compare requirements across countries to choose ideal partner based on their capabilities and your strategy
Use Cases
16
❶
❷
❸
❶
bull Select multiple countries of interestbull Drill down appropriate requirements view
Compare Detailed Requirementsbull Select specific ICH eCTD requirements bull Compare detailed national regulatory authority-derived Official Regulations and local expertise-based Local Practicesbull Refine results by applying indexing such as product type and pharmaceutical form
❹
❹
❸
View Reportsbull View country-specific reports comprising
bull Key Factsbull Key Requirementsbull Procedure Visualizationsbull Detailed Requirementsbull Sources
❷ Compare Summary Requirementsbull Select requirements based on the ICH eCTDbull Use visual comparisons to identify differences in requirements across selected countries
Cortellis CMC Intelligence Workflow
17
Use Case 01 ndash Registering a new product in a single country
A pharmaceutical client is registering a new product in Brazil and is
contracting the final release and packaging to a local manufacturer
What documents does the local packager need to provide to us for our submission
How a manufacturer protects and packages their product must be demonstrated by sufficient documentation and
testing of said materials
View Report ndash Detailed Requirements
Brazil selected
View Report active
18Use Case 02 ndash Registering a new product in multiple countries
A pharmaceutical client is registering a new product in Brazil Colombia
and Peru and is contracting the final release and packaging to a local
manufacturer
What documents does the local packager need to provide to us for our
submission
What differences in requirements are there across the targeted countries
How a manufacturer protects and packages their product must be demonstrated by sufficient documentation and
testing of said materials
Compare Detailed Requirements
Multiple countriesselected
View Compare Detailed Requirements active
19Use Case 03 ndash Flagging high level differences in requirements across in
multiple countries
A pharmaceutical client is registering a new product in Brazil
Colombia and Peru and is contracting the final release and
packaging to a local manufacturer
What high level differences in requirements are there across the targeted countries
Compare Summary Requirements
Multiple countriesselected
View Compare Summary Requirements active
20
Your partner for the entire innovation journey
Discovery amp Translational Science
Setting the RampD Direction
Regulatory Compliance
Clinical Trials
Business Development amp Licensing Sourcing amp
Manufacturing
IP Protection
Life Science Solutions
Dr Mandakini Goel|Sr Solution Consultant|MandakinigoelClarivatecom| Clarivatecom
14
Partner SelectionFully understand requirements around testing and manufacturing before making decisions around who to partner with
bull Understand official regulations and local practices of potential partner company locations
bull Compare requirements across countries to choose ideal partner based on their capabilities and your strategy
Use Cases
16
❶
❷
❸
❶
bull Select multiple countries of interestbull Drill down appropriate requirements view
Compare Detailed Requirementsbull Select specific ICH eCTD requirements bull Compare detailed national regulatory authority-derived Official Regulations and local expertise-based Local Practicesbull Refine results by applying indexing such as product type and pharmaceutical form
❹
❹
❸
View Reportsbull View country-specific reports comprising
bull Key Factsbull Key Requirementsbull Procedure Visualizationsbull Detailed Requirementsbull Sources
❷ Compare Summary Requirementsbull Select requirements based on the ICH eCTDbull Use visual comparisons to identify differences in requirements across selected countries
Cortellis CMC Intelligence Workflow
17
Use Case 01 ndash Registering a new product in a single country
A pharmaceutical client is registering a new product in Brazil and is
contracting the final release and packaging to a local manufacturer
What documents does the local packager need to provide to us for our submission
How a manufacturer protects and packages their product must be demonstrated by sufficient documentation and
testing of said materials
View Report ndash Detailed Requirements
Brazil selected
View Report active
18Use Case 02 ndash Registering a new product in multiple countries
A pharmaceutical client is registering a new product in Brazil Colombia
and Peru and is contracting the final release and packaging to a local
manufacturer
What documents does the local packager need to provide to us for our
submission
What differences in requirements are there across the targeted countries
How a manufacturer protects and packages their product must be demonstrated by sufficient documentation and
testing of said materials
Compare Detailed Requirements
Multiple countriesselected
View Compare Detailed Requirements active
19Use Case 03 ndash Flagging high level differences in requirements across in
multiple countries
A pharmaceutical client is registering a new product in Brazil
Colombia and Peru and is contracting the final release and
packaging to a local manufacturer
What high level differences in requirements are there across the targeted countries
Compare Summary Requirements
Multiple countriesselected
View Compare Summary Requirements active
20
Your partner for the entire innovation journey
Discovery amp Translational Science
Setting the RampD Direction
Regulatory Compliance
Clinical Trials
Business Development amp Licensing Sourcing amp
Manufacturing
IP Protection
Life Science Solutions
Dr Mandakini Goel|Sr Solution Consultant|MandakinigoelClarivatecom| Clarivatecom
Use Cases
16
❶
❷
❸
❶
bull Select multiple countries of interestbull Drill down appropriate requirements view
Compare Detailed Requirementsbull Select specific ICH eCTD requirements bull Compare detailed national regulatory authority-derived Official Regulations and local expertise-based Local Practicesbull Refine results by applying indexing such as product type and pharmaceutical form
❹
❹
❸
View Reportsbull View country-specific reports comprising
bull Key Factsbull Key Requirementsbull Procedure Visualizationsbull Detailed Requirementsbull Sources
❷ Compare Summary Requirementsbull Select requirements based on the ICH eCTDbull Use visual comparisons to identify differences in requirements across selected countries
Cortellis CMC Intelligence Workflow
17
Use Case 01 ndash Registering a new product in a single country
A pharmaceutical client is registering a new product in Brazil and is
contracting the final release and packaging to a local manufacturer
What documents does the local packager need to provide to us for our submission
How a manufacturer protects and packages their product must be demonstrated by sufficient documentation and
testing of said materials
View Report ndash Detailed Requirements
Brazil selected
View Report active
18Use Case 02 ndash Registering a new product in multiple countries
A pharmaceutical client is registering a new product in Brazil Colombia
and Peru and is contracting the final release and packaging to a local
manufacturer
What documents does the local packager need to provide to us for our
submission
What differences in requirements are there across the targeted countries
How a manufacturer protects and packages their product must be demonstrated by sufficient documentation and
testing of said materials
Compare Detailed Requirements
Multiple countriesselected
View Compare Detailed Requirements active
19Use Case 03 ndash Flagging high level differences in requirements across in
multiple countries
A pharmaceutical client is registering a new product in Brazil
Colombia and Peru and is contracting the final release and
packaging to a local manufacturer
What high level differences in requirements are there across the targeted countries
Compare Summary Requirements
Multiple countriesselected
View Compare Summary Requirements active
20
Your partner for the entire innovation journey
Discovery amp Translational Science
Setting the RampD Direction
Regulatory Compliance
Clinical Trials
Business Development amp Licensing Sourcing amp
Manufacturing
IP Protection
Life Science Solutions
Dr Mandakini Goel|Sr Solution Consultant|MandakinigoelClarivatecom| Clarivatecom
16
❶
❷
❸
❶
bull Select multiple countries of interestbull Drill down appropriate requirements view
Compare Detailed Requirementsbull Select specific ICH eCTD requirements bull Compare detailed national regulatory authority-derived Official Regulations and local expertise-based Local Practicesbull Refine results by applying indexing such as product type and pharmaceutical form
❹
❹
❸
View Reportsbull View country-specific reports comprising
bull Key Factsbull Key Requirementsbull Procedure Visualizationsbull Detailed Requirementsbull Sources
❷ Compare Summary Requirementsbull Select requirements based on the ICH eCTDbull Use visual comparisons to identify differences in requirements across selected countries
Cortellis CMC Intelligence Workflow
17
Use Case 01 ndash Registering a new product in a single country
A pharmaceutical client is registering a new product in Brazil and is
contracting the final release and packaging to a local manufacturer
What documents does the local packager need to provide to us for our submission
How a manufacturer protects and packages their product must be demonstrated by sufficient documentation and
testing of said materials
View Report ndash Detailed Requirements
Brazil selected
View Report active
18Use Case 02 ndash Registering a new product in multiple countries
A pharmaceutical client is registering a new product in Brazil Colombia
and Peru and is contracting the final release and packaging to a local
manufacturer
What documents does the local packager need to provide to us for our
submission
What differences in requirements are there across the targeted countries
How a manufacturer protects and packages their product must be demonstrated by sufficient documentation and
testing of said materials
Compare Detailed Requirements
Multiple countriesselected
View Compare Detailed Requirements active
19Use Case 03 ndash Flagging high level differences in requirements across in
multiple countries
A pharmaceutical client is registering a new product in Brazil
Colombia and Peru and is contracting the final release and
packaging to a local manufacturer
What high level differences in requirements are there across the targeted countries
Compare Summary Requirements
Multiple countriesselected
View Compare Summary Requirements active
20
Your partner for the entire innovation journey
Discovery amp Translational Science
Setting the RampD Direction
Regulatory Compliance
Clinical Trials
Business Development amp Licensing Sourcing amp
Manufacturing
IP Protection
Life Science Solutions
Dr Mandakini Goel|Sr Solution Consultant|MandakinigoelClarivatecom| Clarivatecom
17
Use Case 01 ndash Registering a new product in a single country
A pharmaceutical client is registering a new product in Brazil and is
contracting the final release and packaging to a local manufacturer
What documents does the local packager need to provide to us for our submission
How a manufacturer protects and packages their product must be demonstrated by sufficient documentation and
testing of said materials
View Report ndash Detailed Requirements
Brazil selected
View Report active
18Use Case 02 ndash Registering a new product in multiple countries
A pharmaceutical client is registering a new product in Brazil Colombia
and Peru and is contracting the final release and packaging to a local
manufacturer
What documents does the local packager need to provide to us for our
submission
What differences in requirements are there across the targeted countries
How a manufacturer protects and packages their product must be demonstrated by sufficient documentation and
testing of said materials
Compare Detailed Requirements
Multiple countriesselected
View Compare Detailed Requirements active
19Use Case 03 ndash Flagging high level differences in requirements across in
multiple countries
A pharmaceutical client is registering a new product in Brazil
Colombia and Peru and is contracting the final release and
packaging to a local manufacturer
What high level differences in requirements are there across the targeted countries
Compare Summary Requirements
Multiple countriesselected
View Compare Summary Requirements active
20
Your partner for the entire innovation journey
Discovery amp Translational Science
Setting the RampD Direction
Regulatory Compliance
Clinical Trials
Business Development amp Licensing Sourcing amp
Manufacturing
IP Protection
Life Science Solutions
Dr Mandakini Goel|Sr Solution Consultant|MandakinigoelClarivatecom| Clarivatecom
18Use Case 02 ndash Registering a new product in multiple countries
A pharmaceutical client is registering a new product in Brazil Colombia
and Peru and is contracting the final release and packaging to a local
manufacturer
What documents does the local packager need to provide to us for our
submission
What differences in requirements are there across the targeted countries
How a manufacturer protects and packages their product must be demonstrated by sufficient documentation and
testing of said materials
Compare Detailed Requirements
Multiple countriesselected
View Compare Detailed Requirements active
19Use Case 03 ndash Flagging high level differences in requirements across in
multiple countries
A pharmaceutical client is registering a new product in Brazil
Colombia and Peru and is contracting the final release and
packaging to a local manufacturer
What high level differences in requirements are there across the targeted countries
Compare Summary Requirements
Multiple countriesselected
View Compare Summary Requirements active
20
Your partner for the entire innovation journey
Discovery amp Translational Science
Setting the RampD Direction
Regulatory Compliance
Clinical Trials
Business Development amp Licensing Sourcing amp
Manufacturing
IP Protection
Life Science Solutions
Dr Mandakini Goel|Sr Solution Consultant|MandakinigoelClarivatecom| Clarivatecom
19Use Case 03 ndash Flagging high level differences in requirements across in
multiple countries
A pharmaceutical client is registering a new product in Brazil
Colombia and Peru and is contracting the final release and
packaging to a local manufacturer
What high level differences in requirements are there across the targeted countries
Compare Summary Requirements
Multiple countriesselected
View Compare Summary Requirements active
20
Your partner for the entire innovation journey
Discovery amp Translational Science
Setting the RampD Direction
Regulatory Compliance
Clinical Trials
Business Development amp Licensing Sourcing amp
Manufacturing
IP Protection
Life Science Solutions
Dr Mandakini Goel|Sr Solution Consultant|MandakinigoelClarivatecom| Clarivatecom
20
Your partner for the entire innovation journey
Discovery amp Translational Science
Setting the RampD Direction
Regulatory Compliance
Clinical Trials
Business Development amp Licensing Sourcing amp
Manufacturing
IP Protection
Life Science Solutions
Dr Mandakini Goel|Sr Solution Consultant|MandakinigoelClarivatecom| Clarivatecom
Dr Mandakini Goel|Sr Solution Consultant|MandakinigoelClarivatecom| Clarivatecom
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