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  • 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

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