QP Services

EU marketing authorizations and importation depend on appropriate Qualified Person oversight and declarations, and these obligations are attached to the authorization itself — they cannot be left unaddressed. PharmExpert provides QP services from the regulatory angle: QP declarations for active-substance GMP compliance in dossiers, and QP support for importation and certification.

A QP declaration confirming that the active substance is manufactured to GMP is a required element of many marketing authorization applications. We provide these declarations and the underlying supply-chain and GMP review that makes them sound, so this dossier requirement is met reliably.

Beyond declarations, we provide QP oversight of importation and certification and review the technical agreements that govern the supply chain — ensuring the QP responsibilities flowing from your authorizations are clearly assigned and discharged.

We coordinate QP obligations across your portfolio of authorizations and through lifecycle changes such as variations, and can provide interim or ongoing coverage. The result is QP compliance that supports your submissions and authorizations without gaps.