Case studies · Large international pharmaceutical company

Method transfer and EU retesting for a third-country product launch

A marketing authorisation holder is planning to launch a medicinal product made in a non-EU country. We handle method transfer, EU retesting, import with a logistics partner and batch release. The launch is planned for 2027.

Discuss a similar project QP Batch Release

How it went

Starting point, approach, outcome.

Told plainly, in the order it actually happened.

Topic areas

QP Batch Release Analytical Services Operational QA Support

Responsible for this case

Dr. Thomas Lutz Qualified Person (QP) under § 14 AMG

Dr. Olaf Mundszinger 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.

A marketing authorisation holder is planning to launch a medicinal product manufactured in a non-EU country. For this, it needs a laboratory for EU retesting, a warehouse for physical import, storage and distribution, and a partner to release the batches after import.

The manufacturers also have to be qualified, and the partner is expected to prepare PQRs for ongoing monitoring of product quality.

Approach

What we actually did.

We implement the analytical methods in our laboratory (analytical method transfer) and carry out EU retesting there. We handle import and warehousing together with a logistics partner.

We oversee the GMP-compliant manufacture of the authorised medicinal products and release the batches. We qualify the contract manufacturers through audits. We prepare PQRs for the ongoing monitoring of product quality.

Outcome