SERVICES
Health regulation
Our Health Regulation Department has an interdisciplinary team of pharmaceutical chemists, lawyers, doctors and veterinarians, allowing us to provide a comprehensive service in regulatory health issues to our customers, ranging from the importation or manufacture of the product, to its placement and commercialization in the market.
We have specialized in the provision of services to the pharmaceutical industry and the health sector, consolidating national and international relationships with companies and regulatory entities, which makes our Regulatory Law Department one of the most professional and competitive in the market.
We have special knowledge of the Colombian health system, particularly about the acquisition and purchase of medicines, participation in tenders and auctions, which allows us to advise our customers on the processing, obtaining, distribution and marketing of their products.
We have a highly specialized team and experience in high cost drugs, such as biological and biosimilar (Decree 1782 of 2014 and subsequent regulations). We also have proven experience in advisory and procedures with the ICA for animal health and plant care products.
Our services in this area include
Products for human use
Preparation, revision and request of sanitary registrations with the INVIMA - National Institute of Surveillance of Medicines and Foods.
- Medicines
- Diet Supplements
- Medical devices
- Foods and beverages
- Alcoholic drinks
- Cleaning
Structuring of projects in pharmaceutical topics; advisory on the implementation of CAAC, BPM, BPE
Processing of sanitary registrations at international level.
Management and administration of health registration portfolios in Colombia and any country worldwide.
Defense for administrative investigations for infringement of the health regulation in the INVIMA.
Comprehensive and interdisciplinary legal advice in the field of life sciences including: pharmaceuticals, biotechnology, health care, vaccines, food, agricultural products and cosmetics, as well as medical and diagnostic devices.
Advisory in the management of the life cycle of these products, from the registration of trademarks and patents, to the processing of sanitary registrations, drafting license and collaboration agreements, labeling and advertising.
Products for animal use
Preparation of application, revision and application of health registrations with the ICA - Colombian Agricultural Institute:
- Medicines
- Ectoparasiticides
- Foods
- Cosmetics
- Other Products
We have the support of a Veterinarian Doctor to assist us in scientific subjects and in the resolution of technical opinions of the different categories of products.
We perform the diagnosis of the current state of the regulatory processes conducted by the company before the ICA.
We structure, and if necessary, organize and prepare the documentation to file in the ICA.
We advise companies on scientific issues to establish indications, contraindications and precautions of products.
We advise in scientific subjects to answers health opinions of applications of license of sales or any other requirement with the ICA.
