Qualified Person Services

QP Services

Qualified Person (QP) services at VelaLabs ensure that medicinal products – particularly biologics, ATMPs, and clinical trial materials – are certified and released in full compliance with EU regulatory requirements.

We are fully equipped to manage product release not only within the European Union but also for UK or markets falling under a Mutual Recognition Agreement (MRA) e.g. USA, Japan, Israel.

Furthermore, we offer re-testing and confirmatory laboratory services for manufacturers outside of the EU/MRA regions, ensuring that their products meet the stringent standards required for batch release.

Our QPs are responsible for confirming that each batch has been manufactured, tested, and controlled in accordance with:

• EU GMP (EudraLex Volume 4)
• Marketing Authorization / IMPD / CTA requirements
• Applicable regulatory commitments (EMA/FDA where relevant)

This service is critical for:

• Clinical trial supply
• Market release in the EU
• Importation and certification of products manufactured outside the EU

We do not treat batch release as a formality – our approach integrates scientific evaluation, risk-based decision-making, and deep regulatory expertise to ensure patient safety and product quality at every step.

Our Portfolio

• Our QP services support a broad range of use cases:
• Batch certification and release for clinical trial materials (IMP)
• Commercial batch release (EU market)
• Importation and certification of third-country manufactured products
• GMP Audit Services (API, Finished Product, Excipients, contract laboratories and critical raw material suppliers)
• QP Declaration Issuance for Marketing Authorization or Clinical Trials
• Stability data assessment for release decisions
• Deviation, OOS, and change control impact assessment on batch release
• Vendor/supply chain oversight for release readiness

Our Commitment

With experienced Qualified Persons and a strong quality-driven culture, we provide reliable, compliant, and efficient batch certification services tailored to complex biologics and advanced therapies.

We ensure that:

• Every batch meets the highest regulatory standards
• Risks are identified and managed proactively
• Processes remain transparent, efficient, and inspection-ready