Overview

Geographically placed in proximity of the U.S., Puerto Rico attracts foreign investments for medicinal products and medical devices. To obtain market approvals, manufacturers or new entrants must first approach Department of Health (Departamento de Salud). Unlike other states, Puerto Rico’s unique requirements for marketing or selling pharmaceutical products require a fool proof regulatory strategy from the foreign manufacturers.

As expert Regulatory affairs consulting service provider, Freyr assists manufacturers to navigate the region with utmost compliant procedures. Freyr’s Regulatory services in Puerto Rico span across:

  • Medical Devices
  • Drugs
  • Food and Dietary Supplement

Freyr Capabilities

  • Strategic Regulatory Consulting
  • Regulatory Affairs & Regulatory intelligence
  • Registration pathways and license management services
  • Dossier Management

Freyr Advantages

  • 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