QP Services

EU law requires that every batch released to the market be certified by a Qualified Person, and that imported product is supported by appropriate QP oversight and declarations. The QP carries real legal accountability for product released, so this is a role that cannot be a formality. PharmExpert provides QP services and support to meet these obligations reliably.

Our QPs and QP-support specialists provide batch-certification support under EU GMP Annex 16, QP oversight of manufacturing and importation, and QP declarations confirming active-substance GMP compliance for your dossiers. We review the supply chain, technical agreements and the quality of the underlying GMP, because a certification is only as sound as the system behind it.

Where deviations, OOS results or changes affect a release decision, we provide the impact assessment and judgment the role demands — neither waving product through nor blocking it without basis. This is exactly the kind of substantive QP oversight inspectors expect to see evidenced.

We can provide interim coverage during transitions, ongoing QP services, or QP declarations to support specific submissions — backed by the documentation and governance that withstand inspection. The result is compliant, defensible release without the cost or delay of building the capability in-house.