SECTORS
More than 30 years providing solutions to legal and regulatory specialist at the major industries of the health sector in Colombia
We advise to national or international laboratories in all the paperwork regulatory to the INVIMA: medical records of medications, obtaining gmp (Good Manufacturing Practices), modifications, renewals, and penal proceedings. We provide accompaniment integral from the development stage to commercialization.
We represent companies in the cosmetic sector in obtaining Notifications Mandatory Health (NSO) and the regulatory compliance of the andes (Decision 516). We advise on product classification, labeling and regulatory good practices of manufacturing cosmetics.
We support food companies in the procurement of health records, notifications, health and permissions of marketing to the INVIMA. We advise on labeling, nutritional, advertising of foods and compliance colombian technical standards.
We manage health records and import permits for alcoholic beverages before the INVIMA, and other regulatory bodies. We advise on compliance with the requirements of the labelling, advertising and quality control.
We advise manufacturers and importers of medical devices and biomedical equipment in obtaining medical records, certificates of storage capacity and conditioning (CCAA), and compliance of the Decreto 4725 de 2005.
To manage notifications sanitary products of domestic hygiene and absorbent personal hygiene before the INVIMA. We advise in classification of goods under the Decision 706 of the CAN and compliance with labeling requirements.
We advise companies that handle chemical substances and products controlled in the obtaining of the Certificate of Lack of Reports on the Trafficking of Narcotic drugs (CCITE) to the Ministry of Justice, and in compliance with the regulations for precursor substances.
Contact us for a personalized evaluation of your regulatory needs
Regulatory consulting and legal representation specialist for the pharmaceutical, cosmetic, food and medical devices since 1984.
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