HOW WE WORK

To submit a clinical trial to a Regulatory Authority in Brazil, an international client needs to be represented by a local company. We get a Power of Attorney (or Delegation of Responsibilities) from our clients in such cases and submit their studies on their behalf, as our company is registered at ANVISA (Brazilian Ministry of Health).

​

Additionally, our National Ethics Committee (CONEP) requires a certificate of insurance issued locally. This certificate cannot be a global certificate of insurance only translated into local language. The insurance itself needs to be issued locally, meaning by a local company. For this reason, our company also liaises with the insurer to issue this certificate for the study.

​

In other words, any international client needs a local partnership to conduct a clinical trial in Brazil. And we facilitate all this, in a combo service with regulatory affairs, project management and monitoring services. Of course, we also support contracts preparation / negotiation and payments to the vendors and sites.

​

In some cases, the sponsor contacts the sites directly, and, as the sites are somehow experienced with Ethical Regulatory Approval process, they move forward with the study submission to the Local/ National Ethics Committee and start the study with no ANVISA approval/ notification. It is important to remark that no always the sites have experience enough with ANVISA requirements, and we can support the sponsors in this submission process either for approval or notification. 

​

Please contact us to learn more.