Nonclinical (Preclinical) Development

  • Our preclinical experts will establish the preclinical development plan of your candidates, based on the most recent national and international regulations and guidelines,  scientific knowledge and non-confidential competitive information from the public domain. For each study, a comprehensive synopsis describing the animal model, procedures and readouts is established  together with the most appropriate moment to conduct the study: pre-phase I, II, III or Product License Application.
  • We establish or review study protocols and reports, write expert reports, select and audit CROs, monitor your studies, and participate in or provide assistance for the presentation of your nonclinical data to regulatory authorities

 

Do the right things only, at the right time and the right way