Pharmaceutical and Sanitary Sector

Regulatory and Sanitary Law, Government Relations and strategic cases involving Brazilian Health Regulatory Agency (ANVISA), Municipal and State Sanitary Surveillance, Ministry of Health (MS), National Advertising Self-Regulating Council (CONAR), National Institute of Metrology, Quality and Technology (INMETRO), and Regulation of the Pharmaceutical Market Regulation Chamber (CMED), such as:

  • Organization and regularization of companies for initiation of activities;
  • Legality of marketing measures in relation to current sanitary legislation;
  • Regulatory strategy for the development, concession and/or renewal of products subject to sanitary surveillance;
  • Due diligences in companies and assets of the Pharmaceutical and Health Care Industry;
  • Regularization of the price of products before the CMED;
  • Monitoring topics of interest to the pharmaceutical and health care industry, which are being debated (or soon to be addressed) in the National Congress, or are under discussion within the Executive Authority and Regulatory Agencies;
  • Follow-up of activities and dialogue with public agents and decision-making bodies;
  • Risk assessment and consultancy to define strategic course of action;
  • Bidding and public procurement, Public-Private Partnerships (PPPs), Productive Development Partnerships (PDPs) and Risk Sharing Agreements;

In addition, we provide assistance in the negotiation, review and drafting of contracts involving the outsourcing of manufacturing, quality control and storage, supply, distribution and pharmacovigilance stages.