Practice Areas

Sectors

Pharmaceutical Industry and Health Products

Our office has increasingly deepened its work in the health sector and has managed to propose viable structures and alternatives, knowing especially not only the regulations issued by the National Agency of Sanitary Surveillance (“ANVISA”), but also the need to act strongly with the Unified Health System (“SUS”).

Among our main activities within the health industry, we highlight:

  • Regulatory actions at the most diverse levels of Sanitary Surveillance (Municipal, State and Federal);
  • Settlement of judicial measures against Public Administration in regard to acts pertaining to local and international inspections of Operation Authorizations (AFE) and Special Authorizations (AE), Certification of Good Manufacturing Practices, Import License and other licenses required to allow for the unit to operate;
  • Obtaining and advising in the registration of health and medical products;
  • Advisory services in clinical research, the Research Ethics Commission (CEP) and the National Commission of Research Ethics.