From the IMPD to release, all from a single source

The sponsor of a clinical trial required a partner experienced in the GMP-compliant manufacture of a new, innovative active substance manufactured in a non-EU country using a multi-stage process, to ensure GMP-compliant manufacture. A partner was also required to take on project management for manufacturing an investigational medicinal product from the active substance, to ensure GMP-compliant manufacture and to carry out the accompanying analytics. The investigational medicinal product for use in the clinical trial was ultimately to be released for use.

Oversight of the GMP-compliant manufacture of the active substance. Conducting audits to qualify the manufacturers. Project management for formulation development and GMP-compliant manufacture of the investigational medicinal product. Preparation of the IMPD and support with submitting the clinical trial application in several countries. Analytics and release of the investigational medicinal product for use in the phase 1 clinical trial.

Successful GMP-compliant manufacture of the active substance in a non-EU country. Identification of a manufacturer for the investigational medicinal product. Oversight of GMP compliance for manufacture of the active substance and investigational medicinal product. Project management, analytics, batch release and regulatory support from a single source.