Services

BioMedEx provides services in the areas of Registration, Quality Assurance and Compliance (both GMP and Drug Establishment Licence regulations), specializing in Pharmaceuticals, Biologics, Feeds, Pesticides and Low Risk Veterinary 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 LRVHP 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
  • Auditing of GLP/GCP trials
  • GMP training
  • Temperature Mapping

Drug Establishment Licensing (DEL)

  • Completion and filing of DEL applications
  • DEL compliance set-ups and renewals
  • 3rd party foreign site Audits
  • Quality Assurance Agreements
  • Site Master File preparation