Overview

Emerging as a strong provider of transitional medicines, the momentum turn towards Norway for investments in medicines and medical devices. To enter the market, manufacturers must obtain market authorizations from the Norwegian Medicines Agency (NOMA), the agency regulating the registrations and licenses. With the complex Regulatory requirements, foreign manufacturers might face certain Regulatory procedural challenges while approaching for necessary market authorizations.

Freyr, as an exclusive Regulatory Solutions and services provider, assists manufacturers to navigate the necessary Norwegian Regulatory documentation, submissions for successful registrations and market approvals. Freyr’s end-to-end Regulatory affairs consulting in Norway span across:

  • Medical Devices
  • Pharmaceuticals
  • Biologics
  • OTC

Freyr Offerings

  • Strategic Regulatory Consulting
  • Regulatory roadmap for market access
  • Regulatory Affairs & Regulatory intelligence
  • Dossier management
  • Regulatory Submissions
  • Pharmacovigilance
  • 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