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Case studies · Sponsor of clinical trials, biotech company

Comparator product procured, labelled and released

An authorised medicinal product was to serve as a comparator in a clinical trial. We oversaw its GMP-compliant procurement and labelling and released the product.

How it went

Initial situation, procedure, result.

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

Topic areas

Medicinal Product Release Secondary Packaging and Labelling of Investigational Medicinal Products

Responsible for this case

Dr. Lenka Taylor Dr. Lenka Taylor Qualified Person (QP) under § 14 AMG

Anonymised. Confidentiality is part of our business; we only name clients with their consent.

Initial situation

What the client came to us with.

An authorised medicinal product was to be used as a comparator product in a clinical trial. For this, it had to be packaged and labelled in a study-specific, GMP-compliant manner. The sponsor needed a partner to release the comparator product for the trial.

Procedure

What exactly we did.

We oversaw the GMP-compliant procurement of the authorised medicinal product and its manufacture as a comparator product, in this case the labelling. We then released the comparator product for use in the clinical trial.

Result

What came out of it in the end.

The clinical trial was conducted. GMP oversight and batch release came from a single source, and manufacture was carried out together with a partner.

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