Eurofins Canada >> Services >> Quality Assurance and Regulatory

Quality Assurance and Regulatory

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Our professional consulting team has in-depth knowledge of Health Canada, U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) regulations to assist you with your quality and regulatory projects.

Pharmaceuticals for sale in Canada must be labelled, registered, and sold in compliance with Health Canada requirements. We use our knowledge to help our clients comply with all legislative requirements to establish a well-designed and correctly implemented pharmaceutical quality system (also known as a Quality Management System) that incorporates good manufacturing practices (GMP) and quality risk management.

Eurofins Bio-Pharma Product Testing provides Regulatory Affairs, Quality Control/Quality Assurance or Compliance (GCP, GLP, GMP) consulting services for pharmaceuticals (Drugs), natural health products (NHPs), medical devices (MDs), cosmetics and over-the-counter products.

Quality Assurance consulting Services

  • 3rd Party Audit services as well as subsequent gap analyses (in Canada and Out-of-Country For Good Manufacturing Practice (GMP) inspections to ensure that relevant Health Canada requirements are met for all types of pharmaceutical products such as active pharmaceutical ingredients (APIs), over-the-counter (OTC) drug products, excipients, and natural health products (NHPs).
  • Development and Implementation of GMP Compliant Quality Systems

    • Prepare and maintain Standard Operating Procedures (SOPs)
    • Host compliance (GMP) inspections by FDA and Health Canada
    • Product release as Quality Control
    • Manage finished product release and stability testing
    • Prepare and maintain product technical dossiers
  • Ongoing Quality Control and Quality Assurance Services
  • Prepare Technical Quality and Pharmacovigilance Agreements
  • Prepare and maintain Standard Operating Procedures (SOPs) for importers, distributors and wholesalers including GAP analysis for firms with existing SOPs.
  • Host or assist with Regulatory (Compliance) Health Canada Inspections (DEL, MDEL, GMP, GVP, API) from Start to Close-out
  • Host or assist with other Inspections/Audits from Start to Close-out

    • Third Party (Supplier)
    • Internal (Self-Inspections)
  • Preparation of Finished Product Specifications to comply with Health Canada requirements and handle future method validation and testing of product based on the specifications
  • Design and implement Stability Studies program

    • to establish shelf life of the product
    • for continuing stability program for existing and new drugs
    • for thermal cycling studies to support temperature excursions from labelled storage conditions
  • Deviation and CAPA management
  • Master Production Documentation review, approval and maintenance including process validations, method validations, batch production records, etc.
  • Generate Annual Product Quality Reviews (APQR) and/or review of APQR for accuracy and evaluate subsequent CAPA requirement
  • Customized Training Services

    • For a new startup to train personnel (including technical, maintenance, cleaning, warehouse, production line and quality staff)
    • For continuing annual GMP training program
  • Managing Product Recalls including Health Hazard Evaluation and recall classification
  • Complaint Handling and Management
  • Pharmacovigilance and Post-Market Surveillance

    • 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) and issue-related summary reports
    • Conduct literature scans, signal detection, identification of trends
    • Prepare, host or provide support for Health Canada Good Pharmacovigilance Practices (GVP) Inspections
  • Site Reference File
  • Temperature mapping and validation of

    • Shipping Containers
    • Transportation Vehicles
    • Storage Areas
  • Transportation Validation Studies of shipping routes for supply chain of regulated products
  • Qualification of

    • Coolers (IQ/OQ/PQ)
    • Freezers (IQ/OQ/PQ)
    • Incubators (IQ/OQ/PQ)
    • Clean rooms (ISO 7 and ISO 8)

Regulatory consulting services

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