Every Investigational Medicinal Product (IMP) used in EU clinical trials must be certified by a Qualified Person (QP) before it can be supplied to trial sites.
Our QP release for IMPs ensures that your clinical trial materials meet all regulatory requirements, from EU GMP compliance to adherence with the Marketing Authorisation framework applicable to investigational products. This is a legally binding certification, giving sponsors confidence that their IMP batches are compliant and ready for clinical use.
This service is not for commercial product release, nor does it cover import licensing, storage, or distribution. It is specifically focused on the legal, compliance-driven release of IMPs for clinical studies within the EU.
We provide structured, inspection-ready QP release services for sponsors, contract manufacturers, and biotech organisations conducting trials. Each batch undergoes thorough documentation review, testing verification, and QP certification to meet EU regulatory standards.
Partner with us to manage your IMP release pathway efficiently and compliantly. Learn more about our EU Import & Batch Release services and ensure your clinical trial materials meet every regulatory requirement before reaching trial sites.
Investigational Medicinal Products (IMPs) are medicines used specifically in clinical trials to assess safety, efficacy, or dosage. Before any IMP can be supplied to clinical sites in the EU, it must undergo a legally mandated release by a Qualified Person (QP). This ensures that each batch complies with EU GMP standards and is produced according to the clinical trial protocol and regulatory requirements.
QP release for IMPs is distinct from commercial drug product release. Unlike finished products intended for the market, IMPs are supplied solely for controlled clinical studies. Each batch is certified by a QP to verify that manufacturing records, testing results, and quality documentation meet the legal obligations set by EU law.
This process is not about import licensing, storage, or general consultancy. It is a regulatory-driven service that provides sponsors, biotech companies, and contract manufacturers with the confidence that every batch entering a trial is compliant, traceable, and legally certified.
Our structured QP release services for IMPs ensure clinical trials proceed smoothly, inspection readiness is maintained, and all regulatory obligations are satisfied before the investigational product reaches trial participants.
The QP release of Investigational Medicinal Products (IMPs) follows a structured, compliance-driven process that ensures every batch is fit for clinical trial use. At Inglasia, we manage this pathway from start to finish, combining regulatory expertise with precise operational oversight.
Our team examines all manufacturing records, protocols, and quality documentation. This step verifies that the batch aligns with EU GMP standards and trial-specific requirements.
We confirm that all analytical testing has been completed, reviewed, and meets the required specifications. This includes technical compliance checks and verification, ensuring batches are EU importation tested by our Qualified QC Vendors. Any anomalies or deviations are flagged for assessment.
Any deviations or out-of-specification results are evaluated. Our QPs ensure corrective and preventive measures are documented and that the batch remains compliant with clinical and regulatory expectations.
The Qualified Person legally certifies the batch under Annex 16 obligations, confirming that it complies with GMP, trial protocol, and safety standards
Once certified, the IMP batch is authorised for distribution to clinical trial sites. Documentation is complete, traceable, and inspection-ready, giving sponsors confidence in compliance and reliability.
Our expertise ensures that every step is handled efficiently and correctly, reducing regulatory risk and supporting smooth clinical trial operations.
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The supply of Investigational Medicinal Products (IMPs) is strictly governed under EU regulations to protect trial participants and ensure data integrity. EU Good Manufacturing Practice (GMP) standards provides the foundation for manufacturing, handling, and quality oversight of IMPs. Every batch must meet these standards before release to clinical sites.
Annex 16 of EU GMP sets out the responsibilities of the Qualified Person (QP) in certifying each batch. QPs are legally accountable for confirming that every IMP batch complies with quality, safety, and protocol requirements. This ensures that clinical trials are supported by products that meet the highest regulatory standards.
Regulatory inspections can occur at any stage, making compliance and traceability essential. Our team’s experience in managing IMP certification ensures that every batch is inspection-ready, with full documentation and risk mitigation in place.
At Inglasia, we combine regulatory knowledge with hands-on expertise in QP release for IMPs. We oversee certification, perform thorough compliance checks, and verify documentation to give clinical sponsors confidence that their trial supplies are fully certified, traceable, and aligned with EU GMP and Annex 16 requirements. With our expertise, sponsors can trust that their IMPs are handled reliably and lawfully throughout the clinical supply chain.
After QP certification, IMPs must transition seamlessly into the clinical supply chain while maintaining compliance and integrity. At Inglasia, we ensure that every batch certified by our Qualified Persons is prepared for safe, traceable, and fully compliant distribution to trial sites across the EU.
Supply Chain Integrity
Our processes guarantee that storage, transport, and handling meet EU GMP standards for clinical trial materials. We verify that temperature controls, packaging, and shipping documentation align with regulatory requirements.
Risk Mitigation
Potential supply chain risks, including deviations, delays, or handling errors, are proactively identified and managed. Our QPs oversee corrective measures to maintain trial timelines and ensure the reliability of investigational products.
Regulatory Traceability & Inspection Readiness
Every batch is fully documented, creating a clear audit trail from release to clinical site delivery. Sponsors and regulators can confidently review all records, knowing that traceability and compliance are maintained throughout the supply chain.
By integrating QP certification with robust supply chain oversight, Inglasia ensures that investigational products reach clinical trials safely, on time, and fully compliant with EU regulatory expectations.
QP Batch Release for IMPs
Every batch of Investigational Medicinal Products (IMPs) entering a clinical trial requires Qualified Person certification. Our QPs review each batch against EU GMP standards, ensuring regulatory compliance before release to trial sites. This is not consultancy or general oversight—our certification is legally binding, providing sponsors with confidence that every batch is compliant and ready for use. Learn more about our broader EU Import & Batch Release services.
We assess manufacturing records, analytical results, and stability data for each IMP batch. Our team ensures that all technical aspects meet the approved clinical trial protocol and Marketing Authorisation documentation, minimizing risk of deviations during trial supply.
All batch release documentation is rigorously checked for completeness and accuracy. Certificates of analysis, storage records, and shipment documentation are verified, creating a traceable audit trail for regulatory inspections.
Any deviations, quality issues, or process changes are carefully evaluated. Our QPs approve corrective measures before release, maintaining clinical trial integrity and regulatory compliance.
Ongoing Release Support
We provide continuous oversight for trial supplies, supporting sponsors in maintaining inspection-ready compliance and ensuring timely, compliant delivery to all trial sites. Our services integrate smoothly with clinical supply operations and link back to our Qualified Person Batch Release Services for a complete compliance pathway.
Any company supplying Investigational Medicinal Products (IMPs) for clinical trials in the EU must ensure legal QP certification before the products can be administered to trial participants. This requirement applies to clinical trial sponsors overseeing studies, biotech companies transitioning from development to clinical supply, and virtual pharmaceutical companies relying on external QP expertise to meet EU GMP compliance.
Contract Manufacturing Organisations (CMOs) producing IMPs on behalf of sponsors also require QP release to maintain lawful trial distribution. Without certified release, their batches cannot be supplied to clinical sites, putting regulatory compliance and trial integrity at risk.
Inglasia provides a fully regulated pathway for QP release of IMPs. Our team ensures that each batch is reviewed, verified, and approved under EU law, giving sponsors confidence that their clinical supplies are compliant, traceable, and inspection-ready. By partnering with us, you secure a reliable, legally compliant certification process that supports successful trial execution across EU Member States.
Companies supplying Investigational Medicinal Products (IMPs) rely on Inglasia because our Qualified Persons (QPs) combine regulatory expertise with practical experience in clinical trial supply. Each QP is fully accountable under EU law, ensuring that every batch released is compliant with EU GMP and inspection-ready.
Our processes are designed to provide consistent risk control and traceable oversight. We review technical documentation, verify testing results, and assess deviations before granting QP certification. This structured approach mitigates regulatory risk and ensures that clinical trial supplies meet all legal and safety requirements.
Sponsors and contract manufacturers trust our QPs not only for their authority but for their proactive management of accountability. Each certification is legally binding, giving you assurance that every batch is approved under full regulatory compliance.
By partnering with Inglasia for IMP release, you gain more than certification—you gain a dependable, accountable pathway that safeguards trial integrity, ensures lawful supply, and aligns with inspection expectations across the EU. Our QPs handle the regulatory obligations, letting you focus on successful clinical execution while knowing your IMPs are fully compliant.
QP release for IMPs is the legal certification of medicinal products used in clinical trials before they can be supplied to trial sites in the EU. It confirms that each batch complies with EU GMP and the approved clinical trial requirements.
Yes. Every batch of an investigational medicinal product must be certified by a Qualified Person before it can be used in a clinical trial within the European Union. Without this certification, IMPs cannot be supplied to trial sites.
IMPs are used exclusively in clinical trials to evaluate safety, efficacy, or dosage, while commercial drug products are approved for market sale. As a result, IMPs follow a clinical regulatory pathway, whereas commercial products follow a market authorisation pathway.
A QP reviews manufacturing records, analytical testing results, clinical trial documentation, and any deviations related to the batch. This ensures the IMP meets EU GMP standards and aligns with the clinical trial protocol before certification.
QP release takes place after manufacturing and testing are complete, and before the IMP is distributed to clinical trial sites. It ensures that only compliant and safe products are supplied for use in studies.
Ensure your Investigational Medicinal Products reach clinical trials fully compliant with EU regulations. As your EU clinical batch release partner, Inglasia provides legally accountable QP certification, inspection-ready documentation, and rigorous compliance oversight.
Every batch we release is verified, assessed, and certified under EU GMP and Annex 16 obligations, giving you confidence that your clinical supply chain meets all regulatory requirements. This is not consultancy—it is legally binding certification handled by experienced QPs.
Take the next step in securing compliant IMP release.
Contact our team today for a consultation or to discuss how our EU Import & Batch Release services can support your clinical trial supply. Partner with Inglasia and ensure your IMPs are certified, traceable, and fully ready for EU clinical trial distribution.
