chartwell actives
TRANSCRIPT
We know the API business inside out
Chartwell ActivesOur Value
JG/MF
01.12.2016
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Our Value
Index
2
Overview
Areas of Expertise
Scope of Work
Chartwell Actives LLC, a USA company with a divison located in Europe (Portugal)
Overview
We know the API business inside out3
We have a team of industry experts withdecades of experience in GMP applied to
API Manufacturing:
Research and Development, Engineering, Quality Control, Quality Assurance and Regulatory Affairs in a US FDA and EU
EDQM environment.
Downstream
Bring your production facilities ready for a successful FDA / EMEA inspection.
Cover all regulatory affairs issues related both with the API and with FDFassisting you in filing DMFs with the FDA and CEP filings with EDQM.
Assist you with all the process optimization/scale up/industrialization thatmight be needed in terms of the API production.
We know the API business inside out4
Overview
Assist you in finding the right IV CMO in the US and in developing thenecessary ANDAs.
Assist you in launching your products in the market.
5
Overview
Our Mission
We know the API business inside out
Develop andproduce APIs andother specialtyingredients througheffective biotech andchemical synthesisprocesses, in fullcompliance withcGMP
Be your western partner of choice
in getting yourproduct to market
Helping you optimize yourcurrent production processes and reach the next level ofregulatory compliance
Index
6
Presentation
Areas of Expertise
Scope of Work
Our Value
Thinking out of the box
Translating science into value
Opening doors to your product
Effective cGMP Compliance
Improved productivity
BUSINESS DEVELOPMENT
RESEARCH &DEVELOPMENT
ENGINEERING
PROCESSES
QUALITY
REGULATORY AFFAIRS
Help bring yourproducts to the
market
Areas of Expertise
We know the API business inside out7
Technology that fits your needs
Helping you in changing the “status quo” of your business Planning
Helping you managing your Product Portfolio for profit; Adding for growth
Tech Transfering IP in, to match your current plant capabilities; Helping you enter high value, sophisticated markets like the US;
Subtracting for profit Tech Transfering IP out, to help you monetize on your dormant knowledge;
Business process improvement Helping you improve/optimize your production processes for better yields and productivity identifying
and breaking process constraints; Helping you in structuring your deals for maximum profit;
Competitive awareness and advantage Helping you predicting the actions of competitors and planning suitable counter strategies to achieve
competitive advantage.
Areas of Expertise
We know the API business inside out8
Areas of Expertise
Process improvement and Optimization towards Process efficiency and costreduction;
Process Development and Scale-up to Commercial scale;
Creation of “in-silico” IP;
Ability to work in multidisciplinary, multi-project environment.
We know the API business inside out9
Areas of Expertise
Project design, installation, commissioning/ qualification and start-up of APIfacilities in compliance with GMP, GEP and GAMP;
Knowledge and expertise to manage and maintain equipment and facilities understrict overall equipment eficiency standards.
We know the API business inside out10
Areas of Expertise
We know the API business inside out11
Strong expertise in API manufacturing through Fermentation and Downstream Chemical Synthesis
Shop-floor experience/ troubleshooting Implementation of methodologies for productivity improvement Goals
Increasing process yields Reducing production cycles Minimizing solvent use and waste generation Optimizing operations
Methodologies Lean Six Sigma Kaizen 5S Statistical Process Control
Areas of Expertise
Implementation and maintenance of cGMP Quality Systems (ICH, FDA and Europeanregulations and guidelines);
Experience in sucessful FDA/ European Authorities Inspections and customer audits;
Auditing API companies world-wide.
We know the API business inside out12
Areas of Expertise
Submission of Regulatory Registrations DMF's in FDA (USA) and Health Canada; CEP (CoS) (EDQM) ASMF’s in European National Agencies (under National Authorization,
Decentralized (DCP) or Mutual Recognition Procedures (MRP)) Schedules in India; Other countries: Russia, South Africa, Latin America;
Management of Regulatory Registrations
We know the API business inside out13
Index
14
Presentation
Areas of Expertise
Scope of Work
Our Value
o Gap Analysis (on-site audit)
o Review of Quality and Regulatory Documents
o GMP audits on behalf of client
o Due Dilligence
o Follow-up
o Workshops
o Lectures
o Support on execution
o Execution itself (in any of our areas of expertise)
ASSESSMENT TRAINING EXECUTION
Scope of Work
15 We know the API business inside out
Business
Development
Need for an API (generic)
A process in need of
development and/or
optimization
To have a process
To find business partners
(API or FDF)
Get it ready for scale-up
o Patent Busting/ alternative chemical pathways devising/ technical legal support
o Dossier busting (inactive DMFs, etc)
o Use our network to find the right partner for your business
o Custom Synthesis
o Contract Research
o Process Optimization (DoE)
o CMA, CPPs and QCA analysis
o Impurity identification, isolation, qualification and synthesis
o Crystallization/ Polymorphism studies (DoE)
o Genotoxic impurities assessment
o Analytical methods development
o Cleaning methods development + swab recovery studies
o Forced Degradation Studies
o Quality Risk Assessment
o Environment & Safety Risk Assessment
o Proof of concept
In near future in our own Lab facilities
Scope of Work
STAGE IF YOU HAVE... AND YOU WANT...HERE’S WHAT
WE CAN DO FOR YOU
16 We know the API business inside out
Scale-up
Registration
Lab scale process
Validated process
Pilot/ Industrial scale
process
Go to market
o Selection of CMO partner (GMP compliance/ Technology assessment)
o Preparation of Technical Package for Technology Transfer
o Raw-material supplier selection and qualification
o Project Management (Tasks, Time and Cost)
o Communication between client and CMO partners
o Troubleshooting/ problem solving
In future in our own Pilot plant facilities
o Working as a team with CMO (roles to be defined case by case):
o Equipment Qualification
o Analytical Methods Validation
o Cleaning Validation
o Manufacturing Process Validation
o Writing (or reviewing) DMF/ eCTD documents
o Submission of registration dossiers
o Answer potential defficiency letters
Scope of Work
STAGE IF YOU HAVE... AND YOU WANT...HERE’S WHAT
WE CAN DO FOR YOU
17 We know the API business inside out
Validation Industrial process Validated process
Improvement
Whenever
An API production facility
a problem
Improve cGMP compliance
status
or
To get ready for authority
inspection (FDA/ EU
agencies)
a solution
o Phase I (to know what needs to be done):
o Gap Analysis on-site audit (referential: ICH Q7)
o Phase II (for implementation of the improvement actions previously identified):
o Training (teach you how to do it)
o Execution of improvement actions:
o Assistance on execution (we do it together)
o Execution (we do it for you)
You decide.
o Technology assessment for Yield improvement
o Introduction to Lean Six Sigma Methodology
o Implementation of 5S Methodology
o Risk-based methodology for Maintenance Programs
o Energy Efficiency Assessment
o Provided we have the know-how, we will use it to design a service that specifically answers your needs
Scope of Work
STAGE IF YOU HAVE... AND YOU WANT...HERE’S WHAT
WE CAN DO FOR YOU
18 We know the API business inside out
Improve productivity
We know the API business inside out
Thank you!
JG/MF
01.12.2016