Overview

Pharmaceutical and health care sector in the Ugandan landscape is diversified with public and private sector involvement. With the major imported medicines’ share the Ugandan Pharma market offers substantial growth opportunities for foreign medicinal products’ manufacturers. However, to enter the region, manufacturers must get approvals from National Drug Authority, Uganda. Enroute, not only the complex Ugandan Regulatory regime, but also the critical Regulatory procedures challenge the manufacturers to obtain market authorizations.

Freyr, as a specialized Regulatory affairs services provider, assists manufacturers to navigate the Ugandan Regulatory procedures inclusive of end-to-end management of Registrations, licenses, and market authorizations. Freyr’s Regulatory services in Uganda span across:

  • Medical Devices
  • Pharmaceuticals/Drugs
  • OTC
  • Biotech

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 preparation and evaluation

Freyr Advantages

  • Strategic and well-versed local regulatory knowledgebase – with NDA (U)
  • 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