Overview

With recent reforms in health system, Bulgaria stands a good bet for medicine and medical device investments. To obtain market access, manufacturers must get authorizations from the Bulgarian Drug Agency, under the supervision of Ministry of Health, Bulgaria. An authorized representative anywhere from the EU region is required to enter the region and without the updated Bulgarian Regulatory knowledgebase navigating through the complex Regulatory procedures might be an uphill task for new market entrants.

Freyr, as a specialized global Regulatory partner, provides Regulatory affairs consulting across Bulgaria enabling manufactures be compliant for in-time product registrations and market authorizations. Freyr’s end-to-end capabilities for Bulgaria span across:

• Medical Devices
• Pharmaceuticals - Generics
• Cosmetics