Overview

With its central location, Tunisia stands as a gateway to Africa offering best business expansion opportunities for foreign medicine and medical device (MD) manufacturers. In addition to the rapidly developed private health care sector investments, Tunisia is leading the race to be the regional medical centre. To enter the region, manufacturers require to obtain the Authorization for Market Commercialization (AMC) from the Directorate of Pharmacy and Pharmaceuticals (DPM) of the Republic of Tunisia. With an obligation to require a local agent for necessary document submissions to DPM, foreign manufacturers might face a great challenge to navigate through the procedures.

Freyr, as a specialist global Regulatory partner, assists foreign manufacturers in decoding the local regulatory requirements and proceed to mandatory Regulatory submissions for streamlined registrations and approvals. Freyr is capable to provide Regulatory services in Tunisia for:

  • Medical Devices
  • Pharmaceutical
  • Cosmetics

Freyr Offerings

  • Strategic Regulatory Consulting
  • Regulatory Affairs & Regulatory intelligence
  • Registration pathways and license management services
  • Market Authorizations
  • Dossier management
  • Regulatory Submissions

Freyr Advantages

  • Strategic and well-versed local regulatory knowledgebase – with DPM, MOH
  • 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