Regulatory

A QP is a legally designated expert responsible for certifying that each batch of a medicinal product has been manufactured and tested in line with EU GMP and applicable regulatory requirements. QP certification is required before a product can be released to the EU market or supplied for use in clinical trials.

QP certification is required for every batch of medicinal product before release in the European Union (EU). This applies to both investigational medicinal products (IMPs) for clinical trials and commercially manufactured products. Certification must be performed by a QP in accordance with EU GMP requirements, particularly Annex 16. Without QP certification, a batch cannot be legally released to the market or supplied to clinical trial sites within the EU.

QP certification includes a review of the supply chain, manufacturing and quality documentation. This typically covers batch records, analytical results, deviations and compliance with the marketing authorisation or clinical trial application. A batch can only be released after this review has been completed satisfactorily.

Yes. Nuvisan’s EU QPs have experience in certifying batches for both clinical trial use and commercial release.

For products manufactured outside the EU, additional steps are required before QP certification and release. These may include confirmation that the manufacturing site operates in compliance with EU GMP, or equivalent standards, review of complete batch documentation, and analytical testing within the EU where required. The QP must ensure that all relevant regulatory requirements are met, including importation controls and compliance with the applicable marketing authorisation or clinical trial application.

Yes. We conduct GMP audits of manufacturers, suppliers and service providers. These audits support vendor qualification, assess compliance with regulatory requirements and contribute to inspection readiness.

Yes. We provide integrated support across manufacturing, clinical trial supply, quality assurance and QP release. This helps simplify coordination, reduce handovers and keep timelines on track.