Regulatory Services

Drugs and Veterinary Drug Pre-mix
  • Drug Establishment Licence Applications
    • Manufacturing, Packaging, Testing, Importing, Distribution and Wholesale activities
    • Annual DEL renewals
    • Amendments for additional Foreign Sites
  • Annual DIN Renewal Forms
  • Evaluation of chemistry and manufacturing documentation for new drug submissions
  • Evaluation of reformulated marketed drug products
  • Product Recall Management

Natural Health Products
  • Site Licence Applications
    • Manufacturing, Packaging, Labelling and Importing activities
    • Foreign Site approvals
  • Quality Assurance Reports
  • Product Licence Applications and Amendments
    • Non-Traditional claims
    • Transitional DIN products
    • Compendial Products
    • TPD Category IV Products
  • Product Recall Management

Medical Devices
  • Preparation of Medical Device Quality Manuals

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