Clinical section of the marketing authorisation dossier
Modules 2.5 und 2.7 (Clinical Overviews und Clinical Summaries)/Expert Reports
On your behalf our experts can compile the clinical parts of the marketing authorisation dossier (Modules 2.5 and 2.7 of the Common Technical Document; human medicinal products; Efficacy Expert Report, veterinary medicinal products). To this end we draw on your investigational findings and other medical and scientific information relating to biopharmacy, pharmacology, efficacy and safety. Naturally, we also conduct our own research and take bibliographical material into account.
Information has to be properly communicated
It is not sufficient just to collect facts: the regulatory basis has a determining influence on the degree of detail and the focal points of Modules 2.5 and 2.7 (human) as well as Efficacy Expert Reports (veterinary). The regulatory basis determines which trials have to be performed for your product and which key points have to be considered. This then has to be convincingly communicated in the context of the clinical modules. Only if this is done in a truly professional manner will the regulatory assessor be convinced of the positive risk-benefit assessment.
Our practised team of physicians, nutritional scientists, pharmacists, and veterinarians has been performing such assignments for more than ten years. In so doing we have secured the highest regulatory acceptance for a complete spectrum of medicinal products – phytopharmaceuticals, biological and high-tech products, as well as line extensions and generics.
