Strategic Regulatory Partner for Success in Canada

  • Tailored Regulatory Support
  • Product Maintenance & Compliance
  • Flexible Regulatory Teams

Greetings from
Freyr Canada

In order to gain access to the Canadian market, foreign manufacturers are obliged to get authorizations from the Health Canada. Though there is no need of authorized representative for obtaining registrations and gain market approvals, the challenge lies with procedural complexities that a foreign manufacturer may find difficult to handle.

Freyr, as a specialist global Regulatory partner, assists foreign manufacturers in decoding the local regulatory requirements and comprehensive product classification based on relevant Health Canada Regulations. In addition, Freyr assists foreign manufacturers with mandatory Regulatory submissions for streamlined registrations and approvals. Freyr is capable to provide Regulatory services in Canada for.

Industries We Serve in Canada

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:

Canada, with some of the stringent guidelines, has one of the best Regulatory systems in the world for medical devices. In Canada, all Medical Devices are regulated by Health Canada, Health Products and Food Branch, Therapeutic Products Directorate, Medical Devices Bureau. Health Canada reviews Medical Devices to assess their safety, effectiveness, and quality before being authorized for sale in Canada as per the Canada Medical Device Regulation SOR/98-282, implemented in 1998. Freyr has been an active partner of medical device companies to help them comply with the Health Canada medical device registration guidelines.

The cosmetics market in Canada is flourishing, with due credit given to teenagers and youth for their increased consumption. In Canada, cosmetics are regulated by Health Canada (HC) under the Food and Drugs Act and Cosmetic Regulations Act. The products are classified based on the representation, composition, and proposed use of the product or level of action. Hence, identifying the right usage criteria is crucial for classification. It may also be noted that sunscreen lotions, toothpaste, anti-dandruff shampoos, and antiperspirants, which exhibit therapeutic effects, are considered drugs by HC. As a well-explored and established market, entering Canada’s cosmetics market poses challenges not only in terms of competition but also in terms of its advanced regulations.

Canada has steady growth and demand for Natural Health Products (NHP). All NHPs sold in Canada are subject to the NHP Regulations, which came into force on January 01, 2004. In Canada, NHPs and foods are regulated under the Food and Drugs Act (FDA) and its associated regulations. Health Canada (HC) is responsible for establishing and enforcing policies, regulations, and standards relating to the health, safety, and nutritional quality of food in Canada. Despite the steady demand, manufacturers may face difficulty delivering an acceptable formulation within the approved ingredient list to obtain market entry for Canada.

Freyr Offerings

  • Strategic Regulatory Consulting
  • Regulatory roadmap for market access
  • Regulatory Affairs & Regulatory intelligence
  • Registration pathways and license management services
  • Regulatory Submissions and approvals
  • Regulatory Labeling
  • Quality Management System (QMS)

Freyr Advantages

  • Strategic and well-versed local Regulatory knowledgebase – with Health Canada and PAAB
  • Expert Regulatory team with proven global RA expertise
  • Proactive and Collaborative approach
  • Quick turnarounds and faster time-to-market
  • Keeping abreast with region-specific legislation and Regulatory guidelines

Our Location in Canada

100 Consilium Place, Suite 200,
Scarborough, M1H 3E3,