We support 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.
