With growing importance for modernization and with signs of increasing investments, Albania offers a good deal of business opportunities for medicines / medical device manufacturers. Regional Health Authority regulates respective Regulatory activities in the region. For foreign manufacturers, navigating the Regulatory regime in Albania stands challenging aspect while approaching for necessary registrations and approvals.

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

  • Medical Devices
  • Pharmaceuticals / Drugs
  • OTC
  • Biotech
  • Cosmetics

Freyr Offerings

  • Strategic Regulatory Consulting
  • Regulatory roadmap for market access
  • Regulatory Affairs & Regulatory intelligence
  • Dossier management
  • Regulatory submissions
  • Pharmacovigilance
  • In-country representation 

Freyr Advantages

  • Strategic and well-versed local regulatory knowledgebase – with National Agency for Drug & Medical Devices
  • 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