Product development


When manufacturing and processing medicinal products and food supplements, precision and reproducibility on the basis of validated formulations and production processes are required. Through our development and transfer activities, we meet these requirements both in production and in analytical quality control. We have a large number of stability chambers for all relevant climate zones available for stability studies, and are able to perform the analytical tests in our own laboratories. Our experts prepare the necessary dossiers for regulatory authorities worldwide.

We take the corresponding CMC aspects into account in the pharmaceutical development of your new medicinal products and also support you in the provision of test samples for all clinical trial phases.

Furthermore, we organize clinical studies for bioavailability or bioequivalence for you with specialized CROs, and take over all the interface tasks to ensure smooth implementation.


Small-scale production

The production of small batches and the documentation play an important role in development. We have the necessary equipment and specially designed premises at our disposal.

FIDELIO Healthcare Limburg GmbH

Mundipharmastraße 2
65549 Limburg an der Lahn
+49 6431 908830
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