Life Sciences

FIUS's Life Sciences practice provides specialized legal counsel to human health, animal health and agricultural-sciences sectors, with strategic positioning in highly regulated and innovation-driven markets.

We combine regulatory and sanitary expertise, a business-minded perspective and a multidisciplinary approach to support strategic matters, business structuring, innovative solutions, new health technologies, special projects, risk and crisis management, and administrative and judicial litigation.

Domestically, we handle matters before agencies such as MS, ANVISA, MAPA, SUS, CONITEC, VISAs, CNS, CMED, CGEN, CTNBio, CONAR, ANS and the professional councils in the health sector. Internationally, we provide advisory support aligned with the rules and guidelines of regulators such as WHO, PAHO, FDA and EMA, among others.

In complex, highly regulated environments, we prioritize legal certainty, support for innovation, and regulatory compliance applicable to products, services and business models in the Life Sciences ecosystem — always with an eye on each client's specific needs and objectives.

Among our main areas of practice:

• Sanitary regulatory counsel;
• Advisory and strategic matters;
• Business structuring;
• Counsel on innovative solutions and new health technologies;
• Special and disruptive projects;
• Risk and crisis management;
• Administrative and judicial litigation;
• Advisory and contentious work before national regulators;
• Advisory support aligned with international regulatory rules and guidelines.

We advise the main sectors and segments in Human Health, Animal Health and Agribusiness, including:

• Pharmaceuticals;
• Medical Devices;
• AI in healthcare;
• Innovation and health technologies;
• Health data;
• Public health;
• Vaccines;
• Advanced therapies;
• Biotechnology;
• Clinical research;
• Healthcare recalls;
• Medicinal cannabis and industrial hemp;
• Hospitals and clinics;
• Pharmacies and drugstores;
• Diagnostic laboratories;
• Healthtechs, biotechs and medtechs;
• Food and beverages;
• Dietary supplements;
• Cosmetics;
• Personal hygiene products;
• Sanitizing products;
• Agrochemicals;
• Agricultural products;
• Bioinputs;
• Seeds;
• Plant varieties;
• GMOs.