Case studies · Mid-sized company, marketing authorisation holder
Manufacturing site transfer: CMC review, transfer plan and support
A marketing authorisation holder is planning to change its manufacturer. We reviewed the CMC documentation, made recommendations on selecting a contract manufacturer and will support the subsequent transfer.
How it went
Starting point, approach, outcome.
Told plainly, in the order it actually happened.
Responsible for this case
Dr. Emmanuel Bey
Qualified Person (QP) under § 14 AMG
Ute Hegener
Information Officer under § 74a AMG
Dr. Barbara Siebertz
Information Officer under § 74a 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 first step was to review the current CMC documentation, including the relevant parts of Module 3. The second step was to support the manufacturing site transfer strategically and operationally.
Approach
What we actually did.
Building on this, we are preparing a transfer plan with the relevant risk assessments and will support the transfer itself, including the required documents and risk assessments.
Outcome
The outcome.
In a similar situation?
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