Clinical Development Support

Your Clinical Development Program needs technical support to make your Clinical Studies a success. It is our passion to deliver high quality Investigational Medicinal Product to minimize the risk of a study failure.  Our support to your Clinical Program covers: 

Clinical Trial Supply
We manage all activities around Clinical Trial Supply for your Phase 1 to 3 Clinical Studies together with best-in-class contract manufactures, which includes:

          Manufacture of Investigational Medicinal Product (IMP)

          Design of packaging configuration

          Primary and secondary packaging

          Blinding – placebo and active comparator controlled studies

          Storage and distribution of IMP

          Batch release of IMP and Qualified Person Services

As the formulation of your compound might contribute significantly to the success of your Clinical Development Program, e.g. in case of a modified-release formulation, a sound understanding of drug release and pharmaco-kinetic/dynamic profile is mandatory. You will benefit from our broad knowledge during the approval process of several Modified Release products in the EU and US with unique drug release /pharmaco-kinetic profiles resulting in superiority over comparators in the Clinical Trials.

Pharmacy Manuals
Drug administration in Clinical Trials is often challenging. We offer to write/ review your Pharmacy Manuals to improve the quality and, thus, increase the safety and efficacy of your drug.

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