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
  • Food & Dietary Supplements

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
  • Dossier preparation, review and management
  • Regulatory Submissions
  • Pharmacovigilance
  • MRP, DCP Registrations
  • QPPV
  • In-country representation 

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