Overview

With massive improvements in healthcare systems and with rapidly growing economy, the Colombian medicinal drug or device market boasts a good deal of growth opportunities for manufacturers who are willing to enter the region. The National Food and Drug Surveillance Institute (INVIMA), the Colombian health regulatory agency, oversees the regulatory activities in the region. To go ahead, it is mandatory to have an authorized representative in the region for navigating through the complex structure of Regulatory submissions.

Freyr with extensive knowledge on regional / local regulatory requirements, assists foreign manufacturers to streamline the Regulatory submissions, thus to fast-track the registrations and approval processes. Freyr’s support for Colombian market span across:

  • Pharmaceutical Drugs / Generics
  • Medical Devices (Class I, IIA, and III) 90/385/ECC, 93/42/ECC and 98/79//EC
  • Cosmetics - EU Regulation 1223/2009 and FD&C Act
  • Food and dietary Supplements 

Freyr Offerings

  • Strategic Regulatory Consulting
  • Regulatory roadmap for market access
  • Regulatory Affairs & Regulatory intelligence
  • Registration pathways and license management services
  • Dossier preparation, review and management
  • Regulatory Submissions
  • Regulatory Labeling
  • MSDS and raw material review for perfumes and finished products

Freyr Advantages

  • 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