The Life Sciences practice at Finocchio & Ustra provides specialized legal counsel to the human health, animal health, and agricultural sciences sectors, with a strategic focus on highly regulated and innovation-driven markets.

We combine regulatory expertise in health matters, business-oriented insight, and a multidisciplinary approach to support strategic initiatives, business structuring, innovative solutions, emerging health technologies, special projects, risk and crisis management, as well as administrative and judicial litigation.

We advise on a nationwide basis on matters involving entities such as MS, ANVISA, MAPA, SUS, CONITEC, VISAs, CNS, CMED, CGEN, CTNBio, CONAR, ANS, and healthcare professional councils. Internationally, we provide advisory services aligned with the laws and regulatory frameworks issued by authorities such as WHO, PAHO, FDA, and EMA, among others.

In complex and highly regulated environments, we prioritize legal certainty, the advancement of innovation, and regulatory compliance applicable to products, services, and business models within the Life Sciences ecosystem, always taking into account the specific needs and objectives of each client and partner.

Our key areas of practice include:

• Health regulatory advisory;
• Strategic and advisory matters;
• Business structuring;
• Advisory on innovative solutions and emerging health technologies;
• Special and disruptive projects;
• Risk and crisis management;
• Administrative and judicial litigation;
• Advisory and litigation before national regulatory authorities;
• Advisory services aligned with international regulatory frameworks.

The practice advises leading sectors and segments within Human Health, Animal Health, and Agro, including:

• Pharmaceuticals;
• Medical devices;
• AI in healthcare;
• Health innovations and technologies;
• Health data;
• Public health;Vaccines;
• Advanced therapies;
• Biotechnology;
• Clinical research;
• Product recalls in the healthcare sector;
• Medical cannabis and industrial hemp;
• Hospitals and clinics;
• Pharmacies and drugstores;
• Diagnostic laboratories;
• Healthtechs, biotechs, and medtechs;
• Food and beverages;
• Dietary supplements;
• Cosmetics;
• Personal care products;
• Sanitizing products;
• Crop protection products;
• Agricultural products;
• Biological inputs;
• Seeds;
• Cultivars;
• GMOs.