Regulatory Affairs Services for Pharmaceutical Products

Health Canada’s Food & Drugs Act

Health Canada’s Food and Drugs Act provides the regulatory framework for the registration and market of pharmaceutical products in Canada.

Find out more about reducing the lengthy and complex pages of the regulations by taking advantage of our 20 years of experience in advising companies on compliance for their products and save time and effort when planning your next project.

Our regulatory affairs services for drug products in Canada work with you to:

      • File your drug submission applications to Health Canada for approval.
      • Manage all post-approval product changes for pharmaceutical products in Canada including label safety assessment updates for product monographs.
      • Provide solutions for you to meet the requirements of Good Manufacturing Practices, Division 2 of the Canadian Food & Drug Regulations including Drug Establishment Licensing (DEL).
      • Assist with third-party product release for your pharmaceutical products in Canada.
      • Oversee registration of your Canadian clinical trial sites so they comply with Health Canada’s Food & Drug Regulations, Division 5.
drug regulations