Life Sciences & Healthcare
We advise pharmaceutical companies, medical device manufacturers and importers, and distributors on dealings with health authorities and on structuring their commercial operations in Argentina.
We have specific experience in nuclear medicine and radiopharmaceutical production, a segment that requires coordinating product registration with ANMAT, facility licensing with the Nuclear Regulatory Authority, and relations with the National Atomic Energy Commission.Our areas of work include:
- Registration of pharmaceutical products under the applicable medicines framework, and of foods, supplements, and cosmetics with ANMAT and INAL
- Medical devices: classification by risk class, registration with ANMAT, manufacturer or importer registration, and obtaining certificates of free sale for export
- Clinical trials and clinical investigations involving medical devices: agreements with trial sites and investigators, informed consent, and the applicable liability framework
- Advertising and promotion rules for healthcare products, and relations with prescribing healthcare professionals
- Registration of radiopharmaceuticals with ANMAT and licensing of relevant radioactive facilities with the Nuclear Regulatory Authority, including individual personnel permits
- Distribution, agency, license, and supply agreements; transfer of ownership of product registrations in corporate transactions; and patents and test data protection
