Services >> Quality Assurance and Regulatory >> Regulatory Consulting Services

Regulatory Consulting Services

Sidebar Image

Eurofins Biopharma Product Testing supports manufacturers, packagers, labelers, 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