Overview

Given the current industry requirements, Costa Rica offers a plausible business opportunities for foreign Drug and Device manufacturers. With the Ministry of Health overseeing all the regulations and market authorizations in Costa Rica, the challenge for foreign manufacturers is to keep abreast with Regulatory trends and amendments in the region. Not alone the Regulatory knowledge, but as mandatory an authorized representative would also be required for necessary approvals.

With an up-to-date Costa-Rican Regulatory knowledgebase along with its end-to-end Regulatory services and solutions, Freyr assists foreign manufacturers for successful market entries. Freyr’s Regulatory services for Costa Rica span across:

  • Medical Devices / In-vitro Diagnostics
  • Drugs
  • Cosmetics
  • OTC
  • Biologics
  • Food and Dietary

Freyr Offerings

  • Strategic Regulatory Consulting
  • Regulatory roadmap for market access
  • Regulatory Affairs & Regulatory intelligence
  • Registration pathways and license management services
  • End-to-end support in registration
  • Device Classification
  • Labeling and artwork support

Freyr Advantages

  • Strategic and well-versed local regulatory knowledgebase – with 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