Case studies · Mid-sized pharmaceutical company and marketing authorisation holder
Qualified Person (QP) and Head of Production provided
A marketing authorisation holder needed a Qualified Person (QP) for batch release and, for a period, a Head of Production. We provided both, and business operations continued.
How it went
Starting point, approach, outcome.
Told plainly, in the order it actually happened.
Topic areas
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.
The client also wanted advice on implementing quality assurance measures within the company. For a period, a Head of Production was needed as well.
Approach
What we actually did.
We also gave the client strategic advice on implementing quality assurance measures and monitored compliance with them.
Outcome
The outcome.
In a similar situation?
Speak directly with Dr. Klaus-Peter Kreth.
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