As a true full-service provider, HERMES PHARMA can act as the sponsor of clinical studies for bioequivalence/bioavailability (BE/BA) during the development of generic products. We can also perform efficacy studies on food for special medical purposes (FSMP).
The advantages for our customers are clear: you need only one partner for the various stages from defining a product concept, product development and clinical studies, through to registration, product launch and routine manufacturing. This approach avoids the time, effort and costs taken to coordinate several companies.
HERMES PHARMA offers:
- A Good Clinical Practice (GCP) quality system for sponsoring clinical studies
- A project management team for sponsoring clinical studies
- Preparation of investigational medicine product dossiers (IMPDs) for the approval of clinical trials by the competent authorities in the European Union
- Production, labeling and release of investigational medicinal products (IMPs)