IMPD/IND Documentation

The Investigational Medicinal Product Dossier (IMPD) represents the basis for approval to conduct clinical trials in the European Union (EU).  In the United States, the Investigational New Drug (IND) serves the same function. Clinical trials are carried out with the approval of relevant authorities.

Syntagon compiles all relevant documentation in a format ready for the CMC dossier, both in US (IND) and EU (IMPD) formats. Using our expertise, we propose the appropriate type of information for a given stage of trials.

To suit each client’s unique processes and deadlines, we are able to evaluate and schedule regulatory strategies in line with your overall objectives.

What we deliver:  All relevant and required data in IMPD or IND format.

For further information regarding IMPD and IND documentation, please see the following links: