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