Regulatory Affairs Services for Drugs
Health Canada’s Food & Drugs Act
Health Canada’s Food and Drugs Act provides the regulatory framework for the registration and market of drugs in Canada.
Good manufacturing practices (GMP) must be followed by foreign manufacturers of drug products, and by Canadian manufacturers, importers and distributors of drug products.
We have expertise in securing approvals for drug products and experience with good manufacturing practices according to Health Canada Good Manufacturing Practices guidelines.
For drug products we can:
- Prepare and submit drug product applications to Health Canada.
- Handle post-license changes such as new ownership, mergers and buy-outs.
- Bring you Canadian manufacturing, importing or distributing facility into GMP compliance.
- Provide on-site GMP training for your staff.
- Perform GMP audits of contract facilities (such as order fulfillment centres) on your behalf.
- Attend Health Canada GMP inspections and manage follow-ups.
- Provide third-party QA release of finished products.