BioMedEx provides services in the areas of Registration, Quality Assurance and Compliance (both GMP and Drug Establishment Licence regulations), specializing in Pharmaceuticals, Biologics, and  Veterinary Natural Health Products.

Regulatory Affairs    

  • Assessment and classification of products according to Canadian regulations
  • Audit/gap analysis of foreign regulatory dossiers
  • Preparation/attendance at pre-submission meetings
  • Compilation of complete regulatory dossiers
  • Assessment/compilation of specific CMC dossiers
  • Assessment/compilation of post-market change dossiers
  • Acting Canadian Regulatory Affairs liaison for many domestic and international companies
  • Completion of VHP applications and labels

Quality Assurance/Compliance

  • GMP gap analysis and facility audits
  • GMP Compliance document system development
  • Preparation for/attendance at/response to on-site Health Canada GMP inspections
  • Batch documentation reviews
  • Acting Canadian QC department for many domestic and international companies
  • Off-site QC Management for importers/distributors/wholesalers
  • Product documentation review/release
  • Analytical testing review
  • GMP training
  • Temperature Mapping

Drug Establishment Licensing (DEL)

  • Completion and filing of DEL applications and amendments, including Table A for API’s
  • DEL compliance set-ups and renewals
  • 3rd party foreign site Audits
  • Quality Assurance Agreements
  • Site Master File preparation