In recent years, Kenya’s pharmaceutical imports have been growing steadily offering a good scope for drug, food supplement, biopharmaceutical, veterinary products, traditional and complementary medicine manufacturers. Though wide range of business opportunities anticipated, manufacturers might face procedural challenges while navigating through the regulations imposed by Pharmacy and Poisons Board (PPB) – the agency responsible for overseeing the trade in pharmaceutical products.

Freyr, as a preferred global Regulatory partner, provides end-to-end Regulatory Affairs services to assist foreign manufacturers to minimize the compliance related risks in effective timelines to enter the Kenyan market. Freyr is capable to expedite the registrations and market approval processes for:

  • Medical Devices
  • Drugs
  • Biopharmaceuticals
  • Veterinary products

Freyr Offerings

  • Regulatory Affairs Consulting
  • Regulatory Process Optimization
  • Regulatory Strategy
  • Preparation and submission of filings
  • Regulatory submissions of marketing authorization applications (MAAs)
  • Pharmacovigilance
  • In-country representation

Freyr Advantages

  • Expert Regulatory team with proven RA expertise
  • Proactive and Collaborative approach
  • Quick turnarounds and faster time-to-market
  • Keeping abreast with international and region-specific legislation and Regulatory guidelines