Quality Assurance and Regulatory Consulting
Our professional consulting team has in-depth knowledge of safety regulations. We use our knowledge to help our clients comply with all legislative requirements.
Pharmaceuticals must be labelled, registered, and sold in compliance with Health Canada and if applicable FDA Regulations.
Eurofins Experchem provides Regulatory Affairs, Quality Control and Quality Assurance consulting services for pharmaceuticals. Our consulting services include:
- Filing of Product Licence Applications
- Development and Implementation of GMP Compliant Quality Systems
- Drafting of Technical Agreements
- Preparation and Implementation of Client SOPs
- Preparation of Finished Product Specs and Stability Studies
- GMP 3rd Party Audits (in Canada and Out-of Country)
- Ongoing Quality Control and Quality Assurance Services
- Assistance with Health Canada Audits from Start to Close-out
- Custom GMP Training
- Handling Quality Complaints and Product Recalls
- Pharmacovigilance
- License Renewals and Amendments
- Label Reviews
- Temperature Excursion and Transportation Studies
- Annual Product Reviews
- Equipment Validation
We support manufacturers, packagers, labellers, suppliers, distributors, importers, warehouses and prospective license holders.