Overview

With a diverse economy combined with large ratio of Pharmaceutical imports, the Republic of Ghana boasts a viable future for foreign medicine and medical device manufacturers to invest in the region. Manufacturers, however, are obliged to obtain market authorizations from the Food and Drug Authority Ghana, the agency which controls registrations and licenses. The complex Regulatory documentation and critical Regulatory requirements might challenge foreign manufacturers to cope up with the Ghana market authorizations.

Freyr’s panel of Regulatory experts with a comprehensive knowledge over Ghanaian Regulatory affairs, assists foreign manufacturers navigate the region’s Regulatory procedural challenges not only in a streamlined manner, but also in a compliant way. Freyr’s Regulatory services in Ghana span across:

  • Medical Devices
  • Pharmaceuticals / Drugs
  • Cosmetics
  • Food and Dietary Supplements
  • Ayurvedic Products

Freyr Offerings

  • Strategic Regulatory Consulting
  • Regulatory roadmap for market access
  • Regulatory Affairs & Regulatory intelligence
  • Registration pathways and license management services
  • Marketing authorizations
  • Regulatory Submissions
  • Submission of Site Master File (SMF), INDs
  • Dossier Preparation
  • Compilation and review of package inserts
  • patient information leaflets and labels
  • Package Insert (PIL)

Freyr Advantages

  • Strategic and well-versed local regulatory knowledgebase – with Ghana Standards Authority, Pharmacy Council, Environmental Protection Authority and Ministry of Health/ Ghana Health Services
  • 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