Posts in Regulatory
Why Gene Therapy Companies like Libella Gene Therapeutics are Looking at Colombia for their Clinical Trials?

Libella Gene Therapeutics —a US-based company— recently chose Colombia to conduct a phase I clinical trial that could represent a breakthrough in the treatment of Alzheimer's disease (AD) using gene therapy. The approval of a gene therapy trial in Colombia takes 30-45 days from the date of submission to an ethics committee. This time may be shorter or longer depending on how fast the ethics committee at the health institution (aka research center) evaluates the study documents. This positions Colombia as one of the countries with the fastest approval time (and lowest cost) in Latin America for gene therapy research. 

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How Can Medical Device Companies Avoid Being Taken Advantage of by a Distributor and Have Total Control over their Sales in Colombia

It is strongly recommended that foreign medical device manufacturers process the registration under their name and not under the local distributor name or else the foreign company will not be able to change or add distributors during the lifetime of the registration, which is 10 years. 

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9 Steps for Medical Device Companies to Register and Sell their Products in Colombia

Colombia has over 48 million residents and is a very strong market for foreign medical device manufacturers. Interested in entering this market? This article explains the process of obtaining regulatory approval from INVIMA, the country's regulator. Topics covered include regulations, classes of devices, appointing an independent representative, review times for the controlled and non-controlled products, and registration timelines.

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