Life Sciences and Healthcare

KVTS Life Sciences and Healthcare practice is a leading reference in the health, biotechnology, pharmaceuticals, food, agriculture, and biodiversity sectors, representing clients across all related segments, including: pharmaceutical ingredients; medicinal products; healthcare products, equipment, and services; clinical laboratories; pharmacies and drugstores; biotechnological products; fresh and processed foods; dietary supplements; beverages; cosmetics; hygiene products; sanitizing products; animal health; plant production; tobacco; and agricultural pesticides and fertilizers.

The team has extensive experience in handling complex matters – involving transactional, advisory, and litigation aspects – both in administrative and judicial spheres, involving regulated products and services. Key areas of the practice include:

• Regulatory affairs: advisory and litigation services involving regulatory agencies at all levels of government (Ministry of Health, ANVISA, CMED, MAPA, State and Municipal Health Secretariats, ANS, among others);
• Writs of Mandamus and other judicial measures against acts of Public Administration, including but not limited to domestic and international Good Manufacturing Practices Certification (GMPC), National and Local Operating Authorizations (AFE / LF), and Import Licenses (LI);
• Advisory services for the establishment of industrial operations in Brazil, with particular focus on obtaining, amending, canceling, and transferring marketing authorizations and licenses, including representation in related administrative defenses;
• Legal advice on administrative matters before agencies such as INMETRO and IPEMs, including legal representation in corresponding administrative proceedings;
• Review, development, and implementation of compliance programs tailored to the regulated sector (covering interactions with government entities; public and private healthcare professionals; and public and private healthcare services);
• Clinical research and its legal ramifications within the CEP/CONEP system;
• Productive Development Partnerships (PDPs), involving technology transfer agreements aligned with the National Medicines Policy;
• Civil liability for defective or inherently risky products: civil litigation involving damages allegedly caused by such products;
• Recalls and related administrative and judicial proceedings concerning consumer protection;
• Genetically Modified Organisms (GMOs), plant variety protection, regularization of bioprospecting activities, and legal compliance for the collection, transportation, and access to Brazil’s biodiversity and genetic resources;
• Legal advice on foreign investments in Brazil, both for the production and importation of health-related goods and services and for mergers and acquisitions;
• Legal advice to healthcare service providers and clinical laboratories;
• Assistance in public procurement procedures: including qualification, preparation of clarification requests, challenges to public calls for tenders, appeals, and participation in public hearings before the bidding authority;
• Administrative contracts: including contractual amendments and defense against the imposition of contractual or administrative penalties;
• Negotiations with the Ministry of Health regarding direct procurement of medications, access, incorporation, and acquisition of pharmaceutical products (CONITEC);
• Health data protection and compliance with applicable regulations, including e-health, telemedicine, artificial intelligence (AI) in healthcare, customized medical devices, electronic health records, and the Internet of Things (IoT).