Setty Regulatory Affairs fully supports technical and legal, for companies operating in medicines area.

Operating Permission

For a company to work in the medicine field it is mandatory to obtain an Operation License (AFE) granted by ANVISA. 

 Setty assists companies in all stages of their regularization, offering full support from the early stages to reach their full commercial regularization.

Registration

After obtaining the Operating permission, it is mandatory to register the medicine products in ANVISA. 

After publication in the Brazilian Official Gazette (D.O.U) the registration holder is allowed to manufacture and/or import the Medicine product in Brazil. 

Services Provided by Setty in Medicine field

• Local Operating Permission;
• ANVISA’s Operating Permission (AFE) for industries, importers, distributors, carriers;  
• ANVISA’s Special Operating Permission (AE)  for industries, importers, distributors, carriers;
• ANVISA’s AFE and AE for Drugstores and Pharmacies;
• Alteration, Expansion, Reduction of Activities in the Operating Permission (AFE); 
• New Medicine Registration;
• Specific Medicine Registration;
• Similar Medicine Registration;
• Generic Medicine Registration
• Biological and Hemotherapic Products;
• Active Ingredient Registration (API);
• Medicine Registration Renewal;
• Post Registration amendment;
• Good Manufacturing Practices Certification (GMP/CBPF), Good Storage and Distribution Practices Certification (CBPAD)