Regulatory Affairs and Quality Services

Regulatory Affairs: Pre-Approval or Post-Approval, our Regulatory Professionals can guide your company through Canada’s regulatory requirements for:

  • Pharmaceuticals
  • Biotechnology Products
  • Veterinary Drugs and Supplies
  • Medical Devices
We compile, publish and provide guidance on technical and process related issues relating to:

  • New Drug Submissions (NDS)
  • Post-marketing submission management
  • DIN applications and renewal
  • Drug Advertising
  • Establishment License requirements
Quality Services: Our facility and staff comply and are up to date on the most current GMP requirements relating to:

  • GMP and license renewal requirements
  • GMP inspections and release of imported products
We are routinely inspected and audited by Health Canada, our clients, and other foreign agencies, including the US FDA.