Case studies · Clinical trial sponsor, small biotech company
Third-country active substance: QP release for a clinical trial
Active substance from a non-EU country, investigational medicinal product for a trial in several European countries: we provided GMP oversight, the IMPD and QP release. The trial went ahead.
How it went
Starting point, approach, outcome.
Told plainly, in the order it actually happened.
Topic areas
Responsible for this case
Dr. Olaf Mundszinger
Qualified Person (QP) under § 14 AMG
Dr. Lenka Taylor
Qualified Person (QP) under § 14 AMG
Dr. Kai Huwig
Qualified Person (QP) under § 14 AMG
Anonymised. Confidentiality is part of our business; we only name clients with their consent.
Starting point
What the client came to us with.
The sponsor also needed a partner to release the investigational medicinal product for use in the clinical trial.
Approach
What we actually did.
We prepared the IMPD and supported the sponsor in submitting the clinical trial applications in several countries. We released the investigational medicinal product for use in the clinical trial in several European countries.
Outcome
The outcome.
In a similar situation?
Speak directly with Dr. Olaf Mundszinger.
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