Regulatory Affairs & Quality Assurance 

Consulting Services

Toll-Free Phone/Fax: 1-866-697-RAQA (7272)

info@raqaconsulting.ca

Services

RaQaC has assisted many companies in making sound business decisions that has enabled them to bring products to the Canadian market as well as maintain market access of products in a cost effective and timely manner, while meeting regulatory and quality compliance. 


RaQaC provides service offerings for the following product categories:

  • Cosmetics

  • Drugs

  • Food

  • Medical Devices (Class 1 to 4)

  • Natural Health Products (NHPs)

Regulatory Affairs

  • Business reviews

  • Clinical Trial Applications

  • Cosmetic Notifications

  • Drug Submissions (Drug Identification Numbers)

  • Export Certificates for Canadian manufacturers

  • Ingredient and formulation review

  • Label and advertising review for compliance

  • Medical device applications (Class 2 to 4)

  • Natural Health Product Licence Applications (PLAs)

  • Product review and feasibility

  • Product submissions and government filings
  • Provincial formulary listing

Quality and GMP
  • Audit preparation, representation and follow-up
  • Transportation carrier selection and cold chain
  • Drug establishment licencing support
  • Electrical safety considerations
  • ISO registrar selection, implementation and support
  • Medical device establishment licencing support
  • Ongoing product support (Drug / NHP release)
  • Recalls and complaint management
  • Site Licence support (Natural Health Products)
  • SOP implementation
  • Transportation of Dangerous Goods and WHMIS
Project Management
  • Timeline (project) and cost (budgeting) recommendations
  • Cross-functional department considerations
  • Product launches
  • Product line extensions
  • Manufacturing changes