Regulatory services in 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 Provides Regulatory services in Colombia

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