Overview

With an outlook of developing economy and efficient Regulatory framework, the Federal Democratic Republic of Ethiopia stands a good opportunity for multinational drug makers. Prior to market entry, drug makers must obtain necessary authorizations from the Food, Medicine and Health Care Administration and Control Authority (FMHACA), the agency which controls the drugs, medical supplies and instruments under the purview of Ministry of Health, Ethiopia. While venturing into Ethiopia, the drug makers must withstand the slow Regulatory procedures and the costs involved with it.

Freyr, as a specialized Regulatory partner and with comprehensive knowledge over Ethiopia’s Regulatory affairs, assists foreign drug makers to navigate the Regulatory procedural challenges in effective timelines. Freyr offers Regulatory services in Ethiopia for:

  • Medical Devices
  • Drugs
  • Biologics
  • Cosmetics
  • Food & Dietary Supplements

Freyr Offerings

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

Freyr Advantages

  • Strategic and well-versed local regulatory knowledgebase – with the FMHACA
  • 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