Case studies · Sponsor of clinical trials, small biotech company

Active substance from a third country, release for the clinical trial

A sponsor without its own QP needed GMP oversight for manufacture in a non-EU country, the IMPD and release of the investigational medicinal product, all from a single source.

Discuss similar case Medicinal Product Release

How it went

Initial situation, procedure, result.

Without embellishment and in the order in which it actually happened.

Topic areas

Regulatory Affairs Medicinal Product Release Strategic GxP Consulting & QA Support Document Preparation

Responsible for this case

Dr. Olaf Mundszinger Qualified Person (QP) under § 14 AMG

Dr. Lenka Taylor Investigational Medicinal Products and GCP

Dr. Kai Huwig Qualified Person (QP) under § 14 AMG

Initial situation

What the client came to us with.

The sponsor of a clinical trial required a partner experienced in the GMP-compliant manufacture of the active substance and the investigational medicinal product, to ensure GMP-compliant manufacture. The active substance is manufactured in a non-EU country. A partner was also required to release the investigational medicinal product for use in the clinical trial.

Procedure

What exactly we did.

Oversight of the GMP-compliant manufacture of the active substance and the investigational medicinal product. Conducting audits to qualify the manufacturers. Preparation of the IMPD and support with submitting the clinical trial application in several countries. Release of the investigational medicinal product for use in the clinical trial in several European countries.

Result