From IMPD to QP release, all from a single provider

The sponsor of a clinical trial had a new, innovative active substance that is manufactured in a non-EU country in a multi-stage process. It needed an experienced partner to ensure that this active substance was manufactured in compliance with GMP.

The active substance was to be made into an investigational medicinal product. For this, the sponsor also needed a partner to take on project management, ensure GMP-compliant manufacture and carry out the accompanying analytical testing. Finally, the investigational medicinal product had to be released for use in the clinical trial.

We oversaw the GMP-compliant manufacture of the active substance and qualified the manufacturers through audits.

For the investigational medicinal product, we took on project management for formulation development and GMP-compliant manufacture. We prepared the IMPD and supported the sponsor in submitting the clinical trial applications in several countries.

Finally, we carried out the analytical testing and released the investigational medicinal product for use in the phase 1 clinical trial.

The active substance was manufactured in compliance with GMP in a non-EU country. A manufacturer for the investigational medicinal product was identified. We oversaw GMP compliance in the manufacture of both the active substance and the investigational medicinal product.

The sponsor receives project management, analytical testing, batch release and regulatory support from a single provider.