Qualified Person (QP) and Batch Release Services Across Europe
Releasing a product to market is a major milestone, but the paperwork shouldn't slow you down. At Apotech, our Qualified Person services keep your supply chain moving across all countries in Europe. We act as the bridge between your production and the patient, making sure every batch is safe, legal, and ready for the EU, UK, and wider European markets.
Our senior QPs don't just sign off on batches. They join your team so compliance feels like a natural part of your day. Whether you are launching your first product or importing from overseas, our Qualified Person and batch release services give you clear, simple direction to stay on track.
Why QP Services Matter
Across the EU, UK, and the rest of Europe, a Qualified Person is far more than a legal requirement. They are the final check that confirms a product is safe for use, and regulators look closely at how these decisions are made.
Our goal is to make sure your release process is more than a box-ticking exercise. It should be a smart, defensible system that protects your business and your patients. Good QP oversight comes down to clear communication and knowing exactly where the risks sit. See what regulators are focusing on in our GMP inspection data insights.
How we support teams with Quality Person (QP) services
Interim and named QP support
We provide interim and named QPs for both commercial products and clinical trials (IMPs), in every country across Europe. This keeps your supply chain active during periods of growth or team change.
Batch release and certification
Our batch release services give you a clear, structured review of your records, confirming everything aligns with EU and UK GMP rules and your licenses. If a problem appears, we move quickly to help you manage deviations before they cause a delay. Our QPs certify and release batches for markets right across Europe.
Importing and global oversight
Shipping products across borders can be tricky. We provide the expert eye needed for products made outside the EU or UK, making sure importation aligns fully with EU regulatory requirements and GMP standards. For deeper assurance on your sites and suppliers, our QP support pairs naturally with independent GMP audits.
What our batch release review covers
Our batch release services follow a clear, repeatable review so nothing is missed:
- Manufacturing and packaging records checked against the batch specification
- Testing and certificate-of-analysis review, including any out-of-specification results
- Supply chain and import status confirmed against your license
- Deviations, changes, and complaints assessed for impact on the batch
- Final QP certification and release for the relevant EU, UK, or wider European market
EU and UK QP certification after Brexit
Since Brexit, the EU and UK run two separate batch release regimes. A UK QP can no longer certify for the EU or EEA, and an EU certification alone no longer covers the UK market. Our senior QPs are qualified under both, so we map out where certification is actually needed instead of duplicating it.
For products entering Great Britain from the EU or EEA, you often need no second UK certification at all. A Responsible Person (Import), or RPi, can recognize the existing EU or EEA QP release, letting you keep one certification and avoid testing the same batch twice. We can act as your RPi or set the route up for you.
Batch release for clinical trials (IMP certification)
A hold-up at IMP certification can stall a whole trial. Before any batch reaches a site, a QP must certify it was made to GMP and matches the approved dossier. Our QPs handle IMP certification alongside commercial release, under Annex 16 and, in the EU, the Clinical Trials Regulation, keeping studies moving across Europe and the UK.
For IMPs made outside the EU or UK, we manage the extra assurance: a QP Declaration of GMP equivalence, a call on whether import testing is needed, and full supply chain review. For Great Britain, imports from an approved country need no recertifying, just QP-overseen verification of the original release, which we can run for you.
Trusted by top-tier teams worldwide
Why choose Apotech for QP services?
We help life sciences companies stay compliant with an embedded model that strengthens your Quality Management System.
Qualified Person experts across Europe
Our senior QPs have worked across all types of manufacturing and every major European region. We make sure your product release follows local laws in each country while fitting neatly into your global business goals.
Inspection-ready oversight
We know how regulators assess a QP's work. Our experts set up systems that hold up in a busy manufacturing site or warehouse, supporting you during inspections by the EMA, MHRA, and other authorities.
Competitive pricing
By drawing on our local network across Europe, we keep travel costs low. That lets us deliver top-tier QP and batch release support that is affordable and led by senior experts.
Flexible, on-demand service
Whether you need a temporary QP, a permanent named partner, or help fixing a compliance gap, we adapt to your needs and budget, and fit right into your existing team.
Featured case studies
Batch Release as EU Qualified Person
Batch Release as EU Qualified Person Introduction Our client is a vertically integrated company in chemical synthesis and manufacturing of generic Active Pharmaceutical Ingredients and Drug Products. Standards and references Scope of work Remote batch certification and release of medicinal products Provide regulatory expertise as requested Review Marketing Authorisation variations Perform training with impacted…
FAQs on Quality Person (QP) Services
At Apotech, we offer full transparency on our Qualified Person (QP) services. We aim to make the process as simple to understand as possible and are always on hand to answer any questions you might have. Here are some of the questions we get asked most often.
Here are some of the questions we get asked most often.