Regulatory Services in Colombia

Strategic Regulatory Partner for Success in Colombia

  • Tailored Regulatory Support
  • Product Maintenance & Compliance
  • Flexible Regulatory Teams

Greetings from
Freyr Colombia

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.

Industries We Serve in Colombia

Colombia presents tremendous opportunities for medical device companies and its healthcare system is renowned for its commitment to patient safety and the quality of medical services and it governs medical devices through INVIMA (the National Institute for Food and Drug Surveillance). INVIMA is the operating authority for Colombia medical device registration.

The Regulatory framework for foods and dietary supplements has been developed by the Colombian Ministry of Health (MOH), encompassing registration and labeling requirements, claims, and marketing authorizations. The designated authority responsible for granting marketing authorizations is the National Institute for the Surveillance of Food and Medicines (INVIMA – Instituto Nacional de Vigilancia de Medicamentos y Alimentos).

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

Our Location in Colombia

Carrera 7 No. 113-43 Piso 18 of 1804,
Bogota, Colombia