Investigational Medicinal Product Dossier (IMPD)


• Before human clinical trials can be started in the European Union (EU), the sponsor must request authorization to conduct clinical trials through a Clinical Trial Authorization (CTA) submission. This application includes a group of scientific documents in an Investigational Medicinal Products Dossier (IMPD).

• ClinScript has excellent experience in writing summaries of information related to the quality, manufacture and control of the Investigational Medicinal Product, data from non-clinical studies and from its clinical use as well as overall risk-benefit assessment.