Overview

With its universal healthcare system, Germany offers a good deal of business opportunities for medicines / medical device manufacturers. The Federal Institute for Drugs and Medical Devices, Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM) oversees / regulates respective Regulatory activities in the region. With the world’s oldest healthcare system and with many reforms followed by, the Regulatory regime in Germany stands one of the toughest to deal with while approaching for necessary registrations and approvals.

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

  • Pharmaceuticals / medicinal products
  • Medical Devices
  • Cosmetics
  • Healthcare(IT)
  • Biologics

Freyr Offerings

  • Strategic Regulatory Consulting
  • Strategic business development focusing on the European market
  • Regulatory roadmap for market access
  • Regulatory Affairs & Regulatory intelligence
  • Registration pathways and license management services
  • End-to-end operational support
  • Dossier preparation, review and management
  • Regulatory Submissions
  • Market assessments
  • Public relations and marketing
  • In-country representation 

Freyr Advantages

 

  • Strategic local health authority contacts – with Federal Ministry of Health
  • 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