Medicine and medical devices manufactures entering the State of Dominican Republic are required to get market authorizations from the Directorate General of Drugs & Pharmaceuticals, under the Ministry of Public Health and Social Assistance. Right from requiring an authorized representative to handling the Regulatory procedures for final approvals, manufacturers need a specialized focus on the region’s Regulatory regime for successful compliance.

Assisting manufacturers to navigate the complex Regulatory procedures, Freyr, as a specialized Global Regulatory partner, provides end-to-end Regulatory affairs consulting services for Dominican Republic. Freyr’s specialized Regulatory services for the region span across:

  • Medical Device
  • Drugs
  • OTC

Freyr Offerings

  • Strategic Regulatory Consulting
  • Regulatory roadmap for market access
  • Regulatory Affairs & Regulatory intelligence
  • Registration pathways and license management services
  • 510k files application

Freyr Advantages

  • Team with 25+ years of strong foothold in the region
  • Proven track record for device registrations and submissions
  • End-to-end cosmetic Regulatory consultation
  • Structured and cost-effective approach to ensure speed to market