IMP Dossiers

IMPD Writing Service

MODEPHARMA offers an Investigational Medicinal Product Dossier (IMPD) writing service. Working with your team and the manufacturer of the IMP, we will formulate this document in accordance with the current EMEA guidelines. With experience in creating both simplified and full IMPD’s, we will minimise the time and effort required from your team and facilitate the clinical trial application procedure.

About Investigational Medicinal Product Dossiers

The Clinical Trials Directive (2001/20/EC) defines the documentation to be submitted to the Ethics Committee as well as to the Competent Authority whenever the performance of a clinical trial is intended. One such document, the IMPD, often creates uncertainty and additional work for the clinical trials team.

The IMPD includes summaries of information related to the quality, manufacture and control of the Investigational Medicinal Product (IMP), and data from non-clinical and clinical studies. In certain situations, for example where the IMP has already been authorised as a medicinal product in one of the EU Member States, a simplified IMPD will be sufficient.

Contact us for further information or a no-obligation quote.