Clinical Research

Regulatory approval of clinical trials using the latest international standards, in accordance with technical requirements established by the most recognized institutions in the world (FDA, ICH, EMA).

Assistance in the development of medical dossiers for products in accordance with the specific rules of the regulatory agency. Assistance in communication with ANVISA and development of strategic regulatory intelligence for project execution.

Research Centers

Identification and contracting of specialized research centers in the field of knowledge in which the product is inserted.

Selection of investigators and specific clinical team for the needs of each project.

Monitoring of the centers to verify compliance with the procedures indicated in the clinical and GCP protocols.

CEP/CONEP

Approval of clinical research with critical evaluation of the main ethical aspects based on international and local criteria.

Evaluation of the study sponsor’s documentation, especially clinical protocol and Informed Consent for harmonization with the requirements of the ethical instance.