Overview

With a rapidly growing economy and with the dominating scenario of foreign imports, the Republic of Yemen intend to attract many foreign medicinal products and medical device manufacturers to invest in the region. To obtain successful market entry, however, manufacturers need to get approvals from the Supreme Board of Drugs and Medical Appliances (SBDMA) and the Ministry of Public Health, agencies responsible for regulation of pharmacy practices, registrations and drug procurement. For sure, the pharmaceutical sector is growing in the region and the same with Regulatory procedural complexities as it involves communication with multiple entities.

As a specialized global Regulatory partner, Freyr offers localized Regulatory services to assist foreign manufacturers navigate the region’s Regulatory regime with ease. Freyr’s Regulatory affairs consulting services for Yemen span across:

  • Medical Devices
  • Drugs

Freyr Offerings

  • Strategic Regulatory Consulting
  • Regulatory roadmap for market access
  • Regulatory Affairs & Regulatory intelligence
  • Registration pathways
  • Market Authorizations
  • Pharmacovigilance

Freyr Advantages

  • Strategic and well-versed local regulatory knowledgebase – with State Agency of Medicine
  • 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