Overview

In order to enter the Belgium region, foreign medicinal product or medical device manufacturers should need an authorized representative from anywhere in the European Union (EU). Manufacturers should notify the local regulatory body - the Federal Agency for Medicines and Health Products (FAMHP) - to get the market access. Located at the heart of the EU, Belgium can be a distribution touchpoint and offers excellent market opportunities for foreign manufacturers. However, apart from must-to-obtain CE marking, the challenge for foreign manufacturers is to navigate the region’s regulatory system in a time-critical registration and approval processes.

With an in-depth understanding of EU Directives, Freyr as a global partner assists manufacturers to enter the region with ease. Freyr's end-to-end Regulatory Affairs consulting for Belgium span across:

  • Drugs
  • Medical Devices

Freyr Offerings

  • Strategic Regulatory Consulting
  • Regulatory roadmap for market access
  • Regulatory Affairs & Regulatory intelligence
  • Regulatory submissions
  • eCTD and NeeS
  • CMC
  • CE Marking
  • Labeling
  • MRP, DCP

Freyr Advantages

  • Strategic and well-versed local regulatory knowledgebase
  • Team with 25+ years of proven RA expertise
  • 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