1

AxSource is your healthcare and Information

Technology solutions provider specializing in

consulting services for pharmaceutical, biologics,

medical device, natural health products,

cosmetics and food industries.

2

AxSource provides clinical, regulatory, compliance, quality assurance,

quality control, engineering and IT business solutions to the

pharmaceuticals, biologics, natural health product, medical devices,

cosmetics, healthcare, information technology and allied industries.

We specialize in start-up operations and new product launches for all your

activities in emerging markets. AxSource consists of a team of highly

qualified consultants who have committed decades of professional

experience in North America, Mexico, Europe & Asia. The Group is

exclusively dedicated to providing

• Regulatory Affairs /Clinical Affairs

• Quality Control & Assurance

• Process Validation &

• Information Technology services

IT & Healthcare Consulting for past 20 years.

3

AxSource Consulting Inc. shall be recognized as a progressive and ethical

enterprise capable of delivering true consulting and professional regulatory

affairs & compliance services.

We will partner with global regulatory agencies and industry associations to support our clients.

We will engage with our clients in order to deliver cost-effective, safe and effective solutions.

We will exceed our customer expectations in delivery of all our projects.

4

Regulatory & Clinical

GMP, GCP GLP & ISO Services

Pharma

Validations

Pre-Inspections

Quality & Compliance

ERP & Device Software

System Integrations

Computer System

Validations

IT Product Development

Pharmacovigiliance

Litigation & Contracts

Training & Development

5

Competency,

knowledge &

experience

We are experts in what we do. Our expertise has been demonstrated over

and over. With over 150 cumulative years in business experience. Senior

Consultants with over 15 years of industry experience.

Satisfied, reference-

able clients

We have highly satisfied clientele. When AxSource assists in the

certification & implementation efforts, both employees and top management

are satisfied.

Stable, experienced

team

We are committed. There is a commitment between the company and the

employees at AxSource. This means stable project teams, depth of

experience and mature processes.

Flexibility and

reach

We are a global player. AxSource can execute projects globally. We can

mobilized consultants & multi-disciplinary teams to assist you whether your

project is large ($50M) or small ($5K).

Cost-conscientious

We think of your bottom line. We provide consulting advice in close

collaboration with our clients utilizing client resources as much as possible.

AxSource supplies leadership, direction and path to successful outcomes.

6

Broad experience in compliance in regulated health industry from low risk to high risk

Senior consultants (>15 years) with global compliance and consulting expertise

Broad experience spanning R&D, pre-clinical/clinical, manufacturing, importation, distribution/logistics, sales, marketing and customer service and post marketing processes

Only health products consulting group in Canada with in-house IT experts

Ground level design planning start ups to valuable risk management services for clients with marketed products

RQBI™ service offering for more mature companies for efficiency and cost management

True “Consulting” and professional services servicing over 50 clients worldwide

Project Management and leading large scale compliance projects in Canada, USA, Mexico, Europe and Asia (China & India)

Current knowledge of technology and process accelerators to optimize quality

Often requested to supply staff for expert opinions in litigations

7

Leverage our partnerships (CROs, Validation, ISO and Legal)

2 Clinical Research organizations (Clinical Studies, Medical writing) as partners in

Canada & India

Information Management & Validation of critical systems in manufacturing, supply

chain and medical devices

Process Engineering & Validation (13 Engineers)

Learning & Development experts

ISO & Third Party Certification (Notified Bodies) organization for medical devices

8

Our success comes down to the following attributes

Ability to adapt to a range of different business sectors within the regulated health products industry worldwide

Pragmatic problem solving to mitigate risks

Innovative approach with lowest business impact

Customer integrated teams

Mentoring and coaching for smooth transition

Honest & ethical foundation

Strong communication skills

On-time project delivery

Client Satisfaction

9

Our RQBI™ Service

In-depth multi-disciplinary

review of inputs and outputs of

• Your Business

and Customer needs

• Your Regulatory strategy

• Your Financial goals

related

• Your Quality & Compliance

Resulting in

• Cost efficiency

• Improved regulatory strategy

• Meeting Management Goals

Legal, Regulatory & Clinical

Product Submissions for Drugs/ Biologics/ NHPs/ Medical devices (Canada, US, EU)

NDS, ANDA, 510K, CTA, PMA, DIN, Master Files, Device Submissions (Class I-IV), NHP (PLA & SLA)

Facility Licensing & Registration (Canada, US, EU)

Inspection preparation & hosting during government inspection (Health Canada & FDA); PAIs,

Mock FDA/HC audits; Consultant audits for HC submittal

QA/Compliance

GxP Design (GCP, GMP, GLP)

New Drug, biopharmaceutical, Device, NHP, Cosmetic for new and existing facilities per global

harmonized requirements

GMP Drug Audits conducted over 60 global facilities. Over 12 Sterilization Facilities.

Supplier, ISO Audits (ISO 13485:2003); Quality Release of Drug Products; Validation

Documentation & Virtual Regulatory & Compliance Service

10

Pharmacovigiliance

Expert Opinions for law firms.

GCP monitoring & Design

GMP Training and Technical Trainingincluding Computer System Validation training. SOP

Training Tool development

Validations

Process Validations including sterilization, depyrogenation, sterile filling, compounding,

packaging, cold-chain etc.

Method Validations and verifications of compendial tests

Computer System Validations: LIMS, SAP R3, MS NAV 2009 R2, JD Edwards, BAAN,

Complaint Handling System, Pharma Process Control System, Formula Control System, QAD,

BizFlow etc.

ERP Practice/ System Integration/ IT Solutions

ERP Implementations, Delivery and Post-Live Support for clients in various Industry Sectors

System Integrations and Interfaces of ERP, MES, LIMS and PCS Systems for various Manufacturing and Distributions Clients

11

Equipment & Facility Validations: WFI & DI Water System, Compressed air, Filter Integrity,

Clean Room Technology, CIP/SIP etc.

Software Solutions developed by AxSource for Distribution, Warehouse Management, Quality-Compliance and Documentation Management

for various Industry Sectors

12

Our clients may be researchers, CROs, manufacturers, importers, distributors, laboratories, contract manufacturers, API manufacturers, logistics, law firms, trade associations, regulatory consulting group and training companies.

We serve as a virtual regulatory provider for many companies.

For full range of services, please

visit www.axsource.ca .

Our offices are located in Milton, Ontario

AxSource Consulting Inc. 336 Bronte Street South

Suite 224-225

Milton, Ontario

L9T 7W6

(905) 854-6059

Contact AxSource today… 13