Qualified Person (QP) Services
Releasing a product to market is a major milestone, but the paperwork shouldn't slow you down. At Apotech, we provide the Qualified Person (QP) support you need to keep your supply chain moving. We act as a bridge between your production and the patient, ensuring every batch is safe, legal, and ready for the EU and UK markets.
Our senior QPs don't just sign off on batches; they join your team to make compliance feel like a natural part of your day. Whether you are launching your first product or importing from overseas, we give you the clear, simple direction needed to stay on track.
Why QP Services Matter
In the EU and UK, a QP is more than just a legal requirement - they are the final check that ensures a product is safe for use. 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 is about clear communication and knowing where the risks are. 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). This keeps your supply chain active during growth or team changes.
Batch release and certification
Our QPs perform a straightforward review of your records to ensure everything aligns with EU and UK GMP rules and your licenses. If a problem pops up, we work quickly to help you manage deviations before they cause a delay.
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, ensuring your importation is fully aligned with EU regulatory requirements and GMP/GDP audit standards.
Trusted by top-tier teams worldwide
650+
Audits conducted in the last year
800
Network of expert GxP auditors
110
Countries covered
Why choose Apotech for QP services?
We help life sciences companies stay compliant with an embedded model that strengthens your Quality Management System.
Global EU and UK Experts
Our senior QPs have worked across all types of manufacturing and different global regions. We make sure your product release follows local laws while fitting perfectly into your global business goals.
Inspection-Ready Oversight
We know how regulators check a QP’s work. Our experts use their experience to set up systems that actually work in a busy manufacturing site or warehouse, supporting you during inspections by the EMA, MHRA, and other authorities.
Competitive Pricing
By using our local network, we keep travel costs low. This allows us to provide top-tier QP 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. We fit right into your existing team to make life easier.
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 Quality 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.