Expertise
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.
Trench Rossi Watanabe has received the CESA Gender Equity Seal in the highest category entitled “Highlight”. This award recognizes law firms that have solid Diversity, Equity and Inclusion initiatives, taking into consideration several fronts, such as internal commitment, strategic planning, communication and participation rate. With a female majority in leadership for years, this recognition reinforces […]
ANVISA published on October 9, in the Official Gazette the new Resolution of the Collegiate Board – RDC nº 430/2020 providing for the Good Practices of Distribution, Storage and Transport of Drugs. This new Resolution revokes Resolution No. 304/2019, which was published almost a year ago, but had not yet entered into force. ANVISA maintained the […]
The Federal Decree No. 10,388/2020, which regulates the take-back system for medicines nationwide, was published last Friday (June 5th, 2020) on an extra edition of the Federal Official Gazette. The regulation will come into force a hundred and eighty (180) days after its publication. The system will cover the structuring, implementation and operationalization of the […]
ANVISA published (May 28) the Resolution RDC No. 392/2020 for defining extraordinary and temporary criteria and procedures for flexing certain specific requirements applicable to the Good Manufacturing Practices and Import of Pharmaceutical Inputs, due to the Coronavirus pandemic. According to the RDC, exceptional and temporally, manufacturers and importers of drugs and pharmaceutical inputs may disregard […]
Market access (a) How has the regulator in charge been addressing the urgent needs for medicines, medical devices and medical supplies? Has the focus been faster review and grant of marketing authorization, or exceptions to or relaxation of import / use / licensing restrictions, or any other available mechanisms? The Brazilian Federal Health Agency (ANVISA) […]
