ENFISA S.A.S.
“ENFISA S.A.S." is a consulting company that helps manufacturers of medical and pharmaceutical devices to register their products including but not limited in medical devices, medications and food supplements for marketing in Colombia.
Provide training and advice to the pharmaceutical and related industry to improve their quality systems, making their processes efficient and helping them to comply with the established standards, thus providing our customers with a service that exceeds their expectations. By 2025 to be recognized by our clients, as one of the first 3 options in the Colombian market to train and advise the medical, pharmaceutical and related industries.
SERVICES
ENFISA S.A.S. has the resources and experience to serve as your legal representative in Colombia and help you bring your medical or pharmaceutical device to the Colombian market. Our company can offer the hosting service for generics, new molecules and medical products of Class I, II and III in Colombia. With more than 75 years of combine experience in the market, ENFISA S.A.S. can help with modifications, processing of import license, renewals and extensions of sanitary records and more. It must maintain its established relations with INVIMA and DIAN while marketing its products in Colombia. ENFISA S.A.S. has the power to help its clients with the management of these important relations in the country.
MARKET ACCESS
Enfisa has been helping medical device and IVD companies with regulatory compliance and market entry since 2014. We maintain offices in 6+ countries, offering a wide range of compliance services, including regulatory strategy, device registration, quality management system
CLINICAL RESEARCH
Clinical studies are an essential step in ensuring your product is safe and effective, and that it fulfills its intended use. Enfisa by clinical research experts provides clinical consulting and strategy services for pre- and post-CE clinical evidence collection for medical devices.
LEGAL REPRESENTATION
Interested in registering and marketing your medical device in Colombia? If you have no local presence in the country, you are required to appoint a Colombia Legal Representative as part of your regulatory approval process. Enfisa is an experienced regulatory
TESTING SERVICES
Having the right scientific data is the key to demonstrate your product’s safety, efficiency, and effectiveness, and we can help you get this data. Products that contact physical parts of human bodies to bring about their purpose may be demanded to demonstrate its safety via
GXP CONSULTING SERVICES
Enfisa offers a full range of GXP consulting services, including GCP, GLP, and GMP compliance.
We provide consulting expertise from development through commercialization for the pharmaceutical, biotechnology, and medical device industries.