Strategic Regulatory Partner for Success in Kosovo

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

Let's Talk


Greetings from
Freyr Kosovo

The modern healthcare system of Kosovo boasts a better business scenario for foreign medicinal product and medical device manufacturers to invest in the region. To enter the region, manufacturers must obtain necessary authorizations from the Kosovo Medicines Agency (KMA) that regulates the production, import and distribution of medicinal products in the region. With the rapidly evolving Pharmaceutical sector and reforms, navigating through the Regulatory regime requires expert regional market knowledge for end-to-end compliance.

Having an expert Regulatory affairs team keeping abreast with the regional Regulatory requirements, Freyr assists foreign manufacturers navigate through the Regulatory procedural challenges involved. Freyr’s Regulatory services in Kosovo span across:

  • Medical Devices
  • Drugs
  • OTC
  • Vaccines & Biotech

Freyr Offerings

  • Strategic Regulatory Consulting
  • Regulatory roadmap for market access
  • Regulatory Affairs & Regulatory intelligence
  • Registration pathways and license management services
  • Pharmacovigilance

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 Kosovo

Contact us now for Expert Guidance and Support