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.
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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.

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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.

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GMP, GCP Pharma
Regulatory &
GLP & ISO
Clinical Validations
Services
Pre- Quality & ERP & Device
Inspections Compliance Software
Computer
System IT Product
System
Integrations Development
Validations
Pharmacovigil Litigation & Training &
iance Contracts Development

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Competency, We are experts in what we do. Our expertise has been demonstrated over
knowledge & and over. With over 150 cumulative years in business experience. Senior
experience Consultants with over 15 years of industry experience.
We have highly satisfied clientele. When AxSource assists in the
Satisfied, reference-
certification & implementation efforts, both employees and top management
able clients
are satisfied.
We are committed. There is a commitment between the company and the
Stable, experienced
employees at AxSource. This means stable project teams, depth of
team
experience and mature processes.
We are a global player. AxSource can execute projects globally. We can
Flexibility and
mobilized consultants & multi-disciplinary teams to assist you whether your
reach
project is large ($50M) or small ($5K).
We think of your bottom line. We provide consulting advice in close
Cost-conscientious collaboration with our clients utilizing client resources as much as possible.
AxSource supplies leadership, direction and path to successful outcomes.

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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

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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

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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
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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

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Legal, Regulatory & Clinical QA/Compliance
Product Submissions for Drugs/ Biologics/ NHPs/
Medical devices (Canada, US, EU) GxP Design (GCP, GMP, GLP)
NDS, ANDA, 510K, CTA, PMA, DIN, Master Files, New Drug, biopharmaceutical, Device, NHP,
Device Submissions (Class I-IV), NHP (PLA & SLA) Cosmetic for new and existing facilities per global
harmonized requirements
Facility Licensing & Registration (Canada, US, EU)
GMP Drug Audits conducted over 60 global
Inspection preparation & hosting during facilities. Over 12 Sterilization Facilities.
government inspection (Health Canada & FDA); PAIs, Supplier, ISO Audits (ISO 13485:2003); Quality
Mock FDA/HC audits; Consultant audits for HC Release of Drug Products; Validation
submittal Documentation & Virtual Regulatory & Compliance
Service
Pharmacovigiliance
Expert Opinions for law firms. GMP Training and Technical Trainingincluding
Computer System Validation training. SOP
GCP monitoring & Design Training Tool development

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ERP Practice/ System
Validations
Integration/ IT Solutions
Process Validations including sterilization,
depyrogenation, sterile filling, compounding,
packaging, cold-chain etc. ERP Implementations, Delivery and Post-Live
Support for clients in various Industry Sectors
Method Validations and verifications of
compendial tests
Computer System Validations: LIMS, SAP R3,
MS NAV 2009 R2, JD Edwards, BAAN, System Integrations and Interfaces of ERP,
Complaint Handling System, Pharma Process MES, LIMS and PCS Systems for various
Control System, Formula Control System, QAD, Manufacturing and Distributions Clients
BizFlow etc.
Equipment & Facility Validations: WFI & DI Software Solutions developed by AxSource for
Water System, Compressed air, Filter Integrity, Distribution, Warehouse Management, Quality-
Clean Room Technology, CIP/SIP etc. Compliance and Documentation Management
for various Industry Sectors

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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

13. Contact AxSource today…
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