Healthcare: Regulatory

The work developed by TozziniFreire’s Life Sciences & Healthcare group covers industry sectors as diverse as healthcare; pharmaceutical ingredients; drugs; biotechnology; medical devices; cosmetics; health and personal hygiene products; tobacco; food; animal feed; pet and vet products and services; and agrichemicals and fertilizers. The team is widely experienced in working with regulatory agencies, including the Brazilian Sanitation Surveillance Agency (Agência Nacional de Vigilância Sanitária - ANVISA), the Ministry of Health, the Ministry of Agriculture (Ministério da Agricultura, Pecuária e Abastecimento – MAPA), and the National Supplementary Health Agency (Agência Nacional de Saúde Suplementar – ANS). The services provided by our group include a wide variety of matters, such as advice on foreign investment and regulatory issues involving company licensing; advice on product registration; mergers and acquisitions; import and export; product liability and recall; negotiation and drafting of distribution contracts; clinical research; tech transfer and Productive Development Partnerships (Parcerias para o Desenvolvimento Produtivo - PDPs); Public-Private Partnerships (PPPs); intellectual property matters; compliance; crisis management; and administrative and judicial proceedings involving sanitation authorities.