Qualified Person (QP) Services for EU and UK Markets

Importing clinical or commercial pharmaceutical and biotech products into the European Union (EU) or the United Kingdom (UK) can be a complex, high-stakes process. One of the central requirements is having a Qualified Person (QP) who can legally certify that each product batch meets the appropriate quality and compliance expectations before release into the market or clinical use. 

FDAQRC offers Qualified Person Services designed specifically to help pharmaceutical and biotech companies to minimize risk, streamline EU batch release, and make sure of smooth access to EU and UK markets.

What Is a Qualified Person?

A Qualified Person is a legally designated expert with the knowledge, technical experience and professional standing necessary to certify that a medicinal product batch meets all required quality and safety standards before it can be released for supply or use in the EU and UK market.

In the EU, no batch of a finished medicinal product may be released without certification by a QP that it complies with applicable standards and marketing authorization requirements. This formal certification is a foundational step in EU batch release and import compliance.

Your Unmatched Network of QP Experts

At FDAQRC, our greatest strength is our people. We maintain a vetted global network of more than 500 consultants spanning 70+ countries, which includes highly experienced Qualified Persons and former industry and compliance officials ready to support your needs. These experts bring deep operational insight into batch certification and QP declaration services across EU and UK markets, helping you anticipate challenges rather than react to them.

Our Core Qualified Person Services

These services are designed to be clear, actionable and business-focused so your organization can move forward with confidence at every stage of the import and release process.

• EU and UK batch certification and release: Expert support to certify batches in compliance with EU and UK standards, enabling legal release into markets or clinical supply.
• QP declarations for investigational medicinal products (IMPs): Preparation and execution of GP declarations for clinical and investigational products to ensure proper documentation of quality and compliance for trials.
• GMP compliance auditing and support: Assessment of manufacturing and quality systems against good manufacturing practice expectations tied to QP responsibilities.
• Supply chain and quality system oversight: Advisory support to make sure that upstream and downstream activities align with release and import expectations.
• Interim QP support for short-term needs: Flexible QP coverage for temporary projects, audits or transitions requiring immediate qualified oversight.
• QP consulting services UK and EU: Tailored consultations on navigating the UK and EU QP landscape, including insights on cross-jurisdictional certification challenges and best practices.

Schedule a Consultation

If your company needs reliable, expert Qualified Person services, including EU batch release, QP consulting services in the UK or QP declaration services, FDAQRC can help. 

Start with a conversation today to explore how we can support your quality and release goals and help you navigate this critical aspect of market entry.