Life Sciences and Healthcare

KVLAW’s Life Sciences and Healthcare area is a pioneer in the areas of health, biotechnology, pharmaceuticals, food, agriculture and biodiversity, representing clients in all related segments: pharmaceutical inputs, medicines, health services, clinical laboratories, pharmacies and drugstores, biotechnological products, natural foods and processed foods, supplements, beverages, cosmetics, hygiene products, medical products, cleaning products, animal health, and crop production, including pesticides and fertilizers. The office also provides advice to the respective sector associations and distributors of medicines and medical products.

The team has experience in complex questions, business issues, advisory and contentious subjects, and administrative or judicial matters, involving regulated products and services, with an emphasis on the following activities:

• Acting in the regulatory area: consulting and administrative litigation related to Health Authorities at various levels of Government (Ministry of Health, ANVISA, CMED, Ministry of Agriculture, Livestock and Supply, State and Municipal Health Departments, ANS, among others);
• Writs of Mandamus and other legal actions against acts of the Public Administration, including, but not limited to, local and international inspections of Certification of Good Manufacturing Practices (CBPF), Company Operating Permits (AFE), Local Operating Licenses (LF), and Import Licenses (LI);
• Consultancy related to the installation of industries in the Country, with special emphasis on obtaining, altering, canceling and transferring product registration and advising on corresponding administrative defenses;
• Consultancy regarding administrative issues involving bodies such as INMETRO and IPEMs, providing advice on corresponding administrative defenses;
• Industry-specific Compliance Programs (relationships with government agencies, public and private physicians, public and private health service providers);
• Clinical Research and its developments in relation to the CEP/CONEP system;
• Partnerships for Productive Development (PDPs), involving technology transfer contracts, in line with the National Plan for Medicines;
• Civil product liability – civil litigation related to damages potentially caused by defective products or inherent risk;
• Recall and administrative and litigation issues related to consumer protection;
• Issues related to Genetically Modified Organisms (GMO);
• Consultancy on foreign investment in the country, both for the production and import of health goods and services and for merger and acquisition operations;
• Advice on issues faced by healthcare providers and clinical laboratories.