Regulatory Consulting Services

Eurofins Biopharma Product Testing in Toronto supports manufacturers, packagers, labellers, suppliers, distributors, importers, warehouses and prospective licence holders.

Establishment Licence Applications and Amendments for Drugs (DEL), Natural Health Products (NHP Site License) and Medical Devices (MDEL) – Acquisition, Maintenance and Renewals include the following activities
- Fabricating
- Packaging
- Labelling
- Testing
- Importing

Regulatory classification of products based on ingredients and label claims.
Product Licence Applications and Amendments for OTC Drug Products (DIN) – Acquisition, Maintenance and Renewals
- Drug Identification Number (DIN-A)
- Drug Identification Number – Disinfectants (DIN-D)
- Drug Identification Number – Category IV (DIN-F)
- Notifiable Change Submission (NC)
- Administrative manufacturer name/product name change/licensing agreements (ADMIN)
Product Licence Applications and Amendments for Natural Health Products (NHP Product License) – Acquisition, Maintenance and Renewals
- Traditional Herbal Medicines
- Homeopathic Products
- Compendial Submissions
- Non-Compendial Class 2 & 3 Submissions
- Finished Product Specifications
Product Licence Applications and Amendments for Medical Devices (MDL) – Acquisition, Maintenance and Renewals
- Class II, III and IV devices
- Private Label products
Label reviews of Drugs, Food, Medical Devices and Natural Health Products for compliance to Health Canada requirements
- Pre-approval label reviews (Product, Carton, Insert, Product Monograph)
- Post-approval label reviews to address regulatory compliance issues with the marketing authorization
- Advertising reviews
- Ingredient reviews
Product Label Development including Drug Facts Table to help maximize claims and expedite product approvals
Cosmetic product consulting
- Labelling reviews (Product, Carton, Insert)
- Advertising reviews
- Ingredient reviews - International Nomenclature for Cosmetic Ingredients (INCI)
- Formulation reviews – against the Hot List
- Regulatory compliance issues
- Cosmetic Notification applications
Post-market Surveillance/Pharmacovigilance
- Establish and implement procedures to receive and analyze Adverse Event (AE)
- Submit and maintain Adverse Drug Reaction (ADR), Adverse Reaction (AR) and Incident Reports records
- ADR/AR evaluation for seriousness and reportability
- Facilitate filing of ADR and Incident reports to Canada Vigilance Program
- Prepare annual summary reports (ASRs, PSURs, PBRERs)
- Conduct literature searches
- Signal detection, identification of trends
- Prepare, host or provide support for Health Canada Good Pharmacovigilance Practices (GVP) Inspection