A biotech startup requested a support to review, supplement and complete the necessary documentation for a clinical trial application

Biotherapy Partners approach

A review of the existing documentation was acomplished, a gap analysis was done, additional studies were performed if necessary, reports were written, the dossier for clininical trial application was prepared filed to regulatory agency, questions from the agency were answered and the clinical trial was initiated.

Results

BP identified the gaps, proposed supplementary studies and contributed to finalize a successful clinicical trial application for FDA.