Case studies · International pharmaceutical services company headquartered in the USA with locations in the EU
Compassionate use programme: QP release
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 the product.
How it went
Starting point, approach, outcome.
Told plainly, in the order 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.
Starting point
What the client came to us with.
Approach
What we actually did.
Outcome
The outcome.
In a similar situation?
Speak directly with Dr. Klaus-Peter Kreth.
No ticketing system, no switchboard passing you on. You will hear back within one to two days.
More case studies
Similar projects.
Clinical trial sponsor, biotech company
Comparator sourced, labelled and released
An authorised medicinal product was to serve as a comparator in a clinical trial. We oversaw its GMP-compliant sourcing and labelling and release...
Read the full case studyClinical trial sponsor, small innovative biotech company
Novel manufacturing process, supported through to phase 2a
A multi-stage manufacturing process with many manual steps was to be automated in compliance with GMP. The phase 2a trial went ahead, and product...
Read the full case studyClinical 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, t...
Read the full case study
