Clinical Trials Manufacturing

Transferring successful concept formulations and processes from the late preclinical development stages to clinical production is an extremely challenging and demanding task. Therefore, an expert understanding of both cGMP manufacturing and regulatory principles is paramount to ensure a seamless and trouble free process.

To offer further integrated services to our clients, Kuecept has extended its activities to provide additional services in the development chain in the form of GMP clinical trial supply manufacture. In partnership with a series of EU and FDA inspected manufacturing facilities, we can develop prototype formulations using our scalable technologies which can then be technology transferred for cGMP manufacture to support early and late phase clinical trials. Working with a dedicated Kuecept project manager and our in-house EU Qualified Person (QP), Dr Ken Caldicott, we can manage all stages of the project on behalf of the client, ensuring that special attention is paid to maintaining cGMP standards during the entire process. Careful coordination with the client and manufacturing site ensures flawless execution of the clinical supply planning.