Overview

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:

  • Medical Devices (neurosurgical devices, implantable, imaging products, and cardiovascular devices as well as wearables and electronic health products)
  • Drugs
  • Cosmetics
  • OTC
  • Natural Health products
  • Biotech/Bio Similar

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