The Good Manufacturing Certification is the quality assurance granted by ANVISA, attesting that the manufacture and/or storage activities are developed in accordance to Brazilian quality legislation.

To work as a Medicine Manufacture and/or Importer it is mandatory to obtain the GMP Certification to be able to register its products in ANVISA.

To became a Medical Device Manufacture and/or Importer can be mandatory the GMP Certification Prior to the Product Registration. 

In some cases, when the company works with sanitizing products and cosmetics the GMP certification is not mandatory for the product registration, however it’s a quality assurance that can make the difference in a competitive market that is observed nowadays.

In addition to the GMP Certification, Setty Regulatory Affairs acts assisting our partners to obtain the Good Storage and Distribution Practices Certification. 

Setty Regulatory Affairs has the infrastructure and qualified personnel to advice you on obtaining the Good Practices Certification, having a complete consulting service for companies located in Brazil and abroad. Covering the processes elaboration stage to the pre-inspection visit, in order to solve any nonconformity found and preparing to company to ANVISA’s audit.

Among the services provided by Setty Regulatory Affairs for the GMP Certification, can be listed:

• Preparation, assembling and following up the whole process inside ANVISA until it’s publication in the Brazilian Official Gazette;
• Pre-inspection in loco
  Internal audit carried out at the company following ANVISA’s standards in order to identify any nonconformity and suggest corrective actions according to Brazilian legislation.
• Tools to accelerate GMP certification achievement
  Setty performs interventions through administrative and judicial procedures in order to make ANVISA issue the GMP certificate in a term inferior of those practiced by ANVISA.