Elaboration of Drug Clinical Development Dossier (DCDD) and Investigational Medical Device Dossier (IMDD), according to the requirements of Anvisa

Elaboration of clinical research brochure and protocols for Phase I, II, and III studies and other documents needed to perform clinical trials with the purpose of supporting a registration in applicable regulatory instances

Feasibility studies

Evaluation, selection and capacitation of study sites for the performance of clinical trials in different therapeutic areas

Initiation of studies (feasibility, qualification and initiation of study sites)

Clinical study monitoring

Guidance on processes related to Plataforma Brasil and Cep [Research Ethics Committee] - Conep System

Elaboration and submission of applicable documentation to the Research Ethics Committee and Regulatory Agency (Anvisa) for approval purposes regarding the clinical trial to be performed in the country

Elaboration and Evaluation of Bioequivalence Study Protocols

Technical Scientific Reports of Efficacy and Safety

Performance of training in regulatory processes and Good Clinical Practice