Strategic Regulatory Partner for Success in Austria

  • Tailored Regulatory Support
  • Product Maintenance & Compliance
  • Flexible Regulatory Teams

Greetings from
Freyr Austria

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:

Industries We Serve in Austria

Austrian government’s healthcare expenditure clearly showcases good market for drug/medicinal products in the country. Aging population and increased health awareness among Austrians are major reasons behind the surging demand for pharmaceutical products. Prior to marketing medicinal products locally, manufacturers must obtain a Market Authorization approved by the Austrian Agency for Health and Food Safety. As per the Directive 2001/83/EC, any new medicinal product shall be registered through a Marketing Authorization Application (MAA) following certain procedures:

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

Looking for Regulatory Support in Austria

Contact us now for Expert Guidance and Support