Our TPIreg QA team offers quality consultation on quality assurance and GMP services for drug products, natural health products, cosmetics and food. With a combined service record of over 40 years our quality assurance specialists can help you navigate through Health Canada requirements to optimize your commercial quality activities. Our team of experts can guide you through:

Canadian QA Representation

  • Full Canadian QA Representation
  • Release of Commercial Drug Product to Canadian/US Market
  • SOP Development
  • Quality Assurance Agreement (QAA) Generation
  • Specification Development (Drug, NPN, Cosmetic)
  • Master Production & Packaging Records Development

Auditing Services

  • GMP Audits: API (ICHQ7A) Drug Products (Canada, US and EU)
  • Analytical Laboratories (Canada, US and EU)
  • Natural Health Products (Canada)
  • Dietary Supplements (US)
  • Supplier Qualification

Canadian Licensing

  • Establishment & Site Licensing
  • Importer of Record Services for Drugs and Natural Health Products
  • Completion of API Table A
  • Review of API compliance documentation

Training

  • Canadian GMP
  • Canadian GMP for Importers & Distributors
  • Auditing Practices
  • Inspection Readiness
  • Quality Assurance Agreements (QAA)
  • Transportation & Shipping of Drug Products

Technical Support

  • Quality Systems Optimization
  • Assistance with Analytical Validation
  • Validation Master Plan Development
  • Process Validation Protocol Review
  • Stability Protocol Development

To find out more about how our team at TPIreg can help you, please call us at 905-690-4343 or email us at .

Therapeutic Products Inc. (TPIreg) – a boutique Canadian consulting firm offering regulatory and quality assurance services to the pharmaceutical and healthcare industry in North America.