Overview

Canada is the second largest pharmaceutical market in North America. The Health Canada is the federal Regulatory body which is responsible to ensure the safe and effective use of drugs and health products in Canada. Strict Regulatory regime of different bodies for Food and Veterinary, Pharma and Biological drugs, makes it challenging for foreign manufacturers to enter the region. Those Regulatory bodies include:

  • Health Canada’s Health Products and Food Branch (HPFB) – for Food, Health and Veterinary
  • Therapeutic Product Directorate (TPD) – for Pharmaceuticals and Medical Devices
  • Biologics and Genetic Therapies Directorate (BGTD) – for Biological and Radiopharmaceutical drugs

Additionally, renewed guidance for Bioequivalence study for a reference listed drug (RLD) procured from countries other than Canada have made it complicated to gain approval.

To navigate new market entrants, Freyr provides comprehensive Regulatory assistance encompassing product development, review of executed data, gap analysis, dossier compilation, review of submission packages and submission of Drug Identification Number (DIN) applications, along with post-approval changes and life cycle management for various pharmaceutical products adhering to Regulatory standards. In addition, Freyr also provides qualitative and strategic support to respond to the Health Authority queries during the review process.

 

Freyr Expertise

  • New Drug Submissions (NDS), Abbreviated New Drug Submissions (ANDS), Drug Identification Number Application (DINA), Drug Identification Number Biologicals (DINB)
  • Evaluation of product and source data from R&D and manufacturing site (executed data) for the CA-Specific Regulatory and submission requirements
  • Compilation and submission of the dossiers in eCTD format
  • Assistance during the ongoing & completed development, and manufacturing of the finished product
  • Master file submissions
  • Updating & implementation of new Regulatory legislations and guidelines
  • Regulatory strategies and value-added improvements in work flow
  • Professional assistance on limits for impurities including Genotoxic impurities, elemental impurities and metals
  • Post-approval changes:
    • DIN holder transfers
    • Post-approval quality changes like:
      • change in manufacturing site, addition/deletion of the site, Batch size change, manufacturing changes, administrative and labeling changes
    • Changes in container closure system
    • Change in primary packaging material supplier
    • Shelf life extension/reduction
    • Addition of new supplier for active substance
    • Inclusion of additional source for starting material for drug substance