The Healthcare and Pharmaceuticals (Life Sciences) team at KLA boasts a portfolio encompassing some of the largest national and multinational companies within the sector.
The team’s scope ranges from regulatory matters to tax aspects, mergers and acquisitions, as well as brand registration and management, considering the peculiarities of the pharmaceutical and health products industries, including those subject to Health Surveillance regulations.
Moreover, the department assists companies in representing themselves before entities such as Anvisa (National Health Surveillance Agency), the Ministry of Agriculture, Inmetro (National Institute of Metrology, Quality, and Technology), and other regulatory bodies.
• Support in developing internal compliance policies, focusing on sector-specific regulatory provisions
• Regulatory consultancy for Brazilian and foreign companies regarding operating authorizations before the National Health Surveillance Agency (ANVISA), local health licenses (at state and municipal levels), and product registrations with health authorities
• Drafting, reviewing, and advising on distribution contracts and outsourcing stages of regulated product production in the health sector
• Client representation before ANVISA, Chamber of Drug Market Regulation (CMED), Ministry of Agriculture, Livestock and Supply (MAPA), National Institute of Metrology, Quality, and Technology (INMETRO), among other regulatory entities, concerning product registrations, medicines, companies, discussions on price adjustments, and in administrative proceedings with sanctioning aspects
• Assistance in conducting clinical studies in Brazil, including analysis and drafting of research contracts and protocols
• Review of advertising campaigns and labels for pharmaceutical and health product industries.
• Assistance in bids involving the acquisition of medicines, health products, and other regulated items
• Aid in importing and exporting products subject to Health Surveillance regulations
• Handling of judicial and administrative proceedings involving regulatory issues
• Participation in meetings representing client interests in regulatory agencies, consumer defense bodies, and the Public Prosecutor’s Office