We have a multidisciplinary team highly specialized in several legal practices, including regulatory, intellectual property, public law, compliance, civil, criminal, transactional and tax. We advise pharmaceutical, medical device, and other companies in the industry to enter the market, grow and achieve excellent results in a wide range of matters, while always anticipating trends.
We have extensive experience in handling complex corporate transactions, regulatory procedures, drug pricing approval, drafting technology licensing and other agreements of the sector and defining market access strategies. We help clients deal with conflicting regulatory regimes and the related impacts of expansion, manufacturing and distribution strategies. We help companies file and protect patents, conduct clinical trials to gain approval for new drugs and products, and comply with rules relating to the collection, use and treatment of patient data.
We have an excellent standing with the National Health Surveillance Agency (ANVISA); the National Research Ethics Commission (CONEP); the Drug Market Regulation Chamber (CMED); the National Supplementary Health Agency (ANS); the Ministry of Agriculture, Livestock and Food Supply (MAPA); the State Health Secretariats; and the municipal health authorities.
We also have a strong presence in litigation involving product liability and unfair competition. We offer support in compliance issues and digital health. We also participate in the drafting of bills and regulations affecting the industry, and we help our clients navigate the complex tax regime applicable to the healthcare sector to optimize their results.