Case studies · International pharmaceutical services company headquartered in the USA with locations in the EU
Compassionate use programme: release granted
Patients were to receive a medicinal product not yet authorised for their indication. We oversaw its GMP-compliant transfer into the compassionate use programme and released it.
How it went
Initial situation, procedure, result.
Without embellishment and in the order in which it actually happened.
Topic area
Responsible for this case
Dr. Klaus-Peter Kreth
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.
Procedure
What exactly we did.
Result
What came out of it in the end.
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