Overview

With its universal healthcare system, Austria offers a good fortune for Medicinal product and Medical Device manufacturers across the globe. To enter the region, however, manufacturers must obtain market authorizations from The Austrian Agency for Health and Food Safety (AGES), an agency looks after the registrations and licensing in the region. Apart from requiring an authorized representative anywhere from the EU region, navigating through various registration processes in Austria might pose a challenge for foreign medicinal product manufacturers hindering the compliance.

Freyr as an exclusive Global Regulatory Partner, assists foreign manufacturers with localized Regulatory Affairs and operational support for needed Regulatory activities. Freyr’s end-to-end Regulatory services for Austria region span across:

  • Medical Devices
  • Drugs
  • Cosmetics, Food & Dietary Supplements
  • OTC

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
  • CE Marking
  • Regulatory Submissions
    • Preparation/compilation of dossiers
    • eCTD/NeeS submissions
    • Life Cycle Management
    • SmPCs/PILs
    • Submission and Management of MRPs and DCPs
  • Due Diligence
  • Pharmacovigilance / XEVMPD, PSUR, PBRER

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