Overview

With growing importance for modernization and with increased government spending towards healthcare, Belarus offers a good bet of business opportunities for foreign medicinal products / medical device manufacturers. To get the market entry, manufacturers must obtain market authorizations from the Ministry of Health, the authority which regulates respective Regulatory activities in the region. For foreign manufacturers, navigating the Belarusian Regulatory regime might stand a challenging aspect for obtaining necessary registrations and approvals.

Freyr with an exclusive Belarusian Regulatory knowledgebase, assists foreign manufacturers with localized Regulatory Affairs and operational support for needed Regulatory activities. Freyr’s end-to-end Regulatory affairs consulting in Belarus span across:

  • Medical Devices
  • Pharmaceuticals
  • Cosmetics
  • Food Supplements
  • Pharmacovigilance

Freyr Offerings

  • Strategic Regulatory Consulting
  • Regulatory Affairs & Regulatory intelligence
  • Registration pathways and license management services
  • End-to-end operational support
  • SmPC, PIL, Artworks Design
  • Dossier preparation, review and management
  • Regulatory Submissions
  • In-country representation

Freyr Advantages

  • 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