Life Sciences

About

Provided by Felsberg Advogados

Felsberg Advogados supports clients in safely navigating the waters of the Brazilian regulatory framework, including:

• Consulting on the regulatory frameworks of the Ministry of Health, National Private Healthcare Agency (ANS), National Health Surveillance Agency (ANVISA) and the Ministry of Agriculture, Livestock and Supply (MAPA);
• Representing clients in sanctioning administrative proceedings before ANVISA, ANS, and the local heath surveillance agencies;
• Advising on the requirements for the granting of Operation Permits (AFE), Special Permits (AE), and local health permits;
• Advising on the rules and regulations for registering products and medications, and during price adjustment discussions;
• Assisting with public bids and contracts;
• Reviewing advertising campaigns and product labels;
• Reviewing policies on compliance and corporate ethics; and
• Reviewing and advising on the distribution and outsourcing contracts needed for the production of controlled medications.