Legal expertise with business vision for the life sciences industry and healthcare services
L.O. Baptista’s Health Care & Life Sciences team is prepared to guide companies in the healthcare sector to face the complex regulatory environment and rapid market transformations. Our team combines legal expertise with an in-depth understanding of the trends and challenges faced by the pharmaceutical, medical device, biotechnology, and cosmetics industries and by healthcare service providers, such as hospitals, research centers, and healthcare providers.
With over a decade of experience working alongside national and international players, we have developed a practice that combines technical excellence with the ability to anticipate needs and support innovative business strategies, including in light of the rules and procedures imposed by the strong performance of the National Health Surveillance Agency (ANVISA), Ministry of Health, Ministry of Agriculture, Livestock, and Food Supply (MAPA), and National Supplementary Health Agency (ANS).
We have a fully dedicated team, concerned with analyzing the rules in order to provide the best advice in decision-making involving relationships with health surveillance agencies, since we offer legal advice in several areas, such as consolidations and acquisitions, tax, labor, contracts, litigation areas, among others.
The area and its professionals are frequently cited by specialized legal publications, nationally and internationally, such as Best Lawyers and Anuário Análise Advocacia.
How we can help:
• Consulting for companies entering or expanding their presence in regulated segments, including corporate planning and guidance for compliance with ANVISA and other authorities.
• Development of regulatory compliance and corporate ethics programs, aligned with the LGPD and market practices, with support in crisis management, such as recalls and rapid adaptations to new regulations.
• Protection of patents, trade dress and trademarks, which includes defense in highly complex litigation and support for research and development agreements.
• Representation of clients in bidding processes and consultancy for Productive Development Partnerships (PDPs) and other public-private collaboration models, with a history of success with the Ministry of Health and other regulatory bodies.
• Legal and strategic support in clinical research and incorporation of health technologies, including compliance in cutting-edge research and medical technology.
• Representation in specialized litigation for the healthcare sector, supporting companies in disputes involving drugs, medical devices, and complex intellectual property litigation.
• Performance in Consultations and Public Hearings opened by ANVISA.
• Consulting for health plan operators on regulatory aspects, especially in compliance with the
guidelines of the National Supplementary Health Agency (ANS), including analysis of agreements with providers, regulatory auditing, and defense in administrative and judicial proceedings.
