QP & Regulatory Services

All clinical trials undertaken in the EU now have to comply with the requirements of The Clinical Trial Directive 2001/20/EC in May 2004. Investigational Medicinal Products (IMPs) manufactured outside the EU must be imported into a licensed site and released by a Qualified Person (QP). This demonstrates compliance with the Clinical Trial Directive.

Understanding and meeting this directive is a complex, but critical step in the development of a Clinical Trials study, therefore we involve QPs up-front during the project scope and feasibility stage.  

Using Piramal’s documented assessment guidelines, our QPs assess the supply-chain quality systems from API, manufacturing, analytical testing, packaging to release.  This ensures any regulatory issues are identified and steps built into the project plan to eliminate their risk.

Our QPs stay with the sponsor to assist during the project and are on hand to support regulatory requirements, applications and final release.