Confidence throughout your clinical studies
Clinical studies involve complex processes and stringent regulatory requirements, particularly when investigational medicinal products (IMPs) need to be imported, packaged, labelled or released within the EU/EEA. A single error in documentation, labelling or batch certification can affect timelines, compliance and patient safety.
Normec supports pharmaceutical and biopharmaceutical organisations with Clinical QP services that ensure quality, regulatory compliance and reliable market access throughout clinical development.
Support for IMPs, labelling and batch certification
Clinical supply chains depend on well-coordinated and compliant processes. That is why we provide specialised Qualified Person (QP) services to support every stage of clinical development.
Our services include:
- Qualified Person services for clinical studies
- Batch certification and release of investigational medicinal products (IMPs)
- Support with Manufacturing and Import Authorisation (MIA) applications
- Small-batch labelling
- Batch certification and batch release
- QP declarations for regulatory submissions
- Support with product recalls and product defects
Our specialists ensure that your processes comply with European regulations and meet the quality requirements for clinical studies.
Efficient and controlled processes
Clinical QP services are about more than regulatory compliance. They ensure that critical processes remain reliable and under control, even in complex international studies involving multiple stakeholders, sites and timelines.
Normec works closely with quality, operations and supply chain teams to improve process efficiency and maintain control. We support organisations with quality assurance, inspection readiness and regulatory compliance throughout clinical development.
With our support, you can:
- Streamline clinical batch release
- Maintain compliant and well-controlled IMP processes
- Reduce risks across your clinical supply chain
- Optimise small-batch labelling processes
- Respond more efficiently to changes in clinical studies and regulatory requirements
Expertise in pharma, biopharma and clinical development
Our specialists have extensive experience in the pharmaceutical and biopharmaceutical industries and understand how quality, documentation and operational processes come together throughout clinical development.
This enables us to provide practical support that is not only regulatorily sound but also effective in day-to-day operations.
Preparing for the future
Normec helps organisations build future-ready Clinical QP processes through specialist expertise, quality assurance and practical support. We help ensure safe, reliable and efficient clinical development programmes across the EU/EEA.
Together, we build robust processes that are ready for the next generation of drug development.
Would you like to know more about Clinical QP services?
Frequently Asked Questions
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Clinical QP services focus on batch certification, quality assurance and regulatory compliance for investigational medicinal products used in clinical studies.
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IMP stands for Investigational Medicinal Product, the medicinal product being tested or used as a reference in a clinical study.
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Small-batch labelling involves labelling limited quantities of investigational medicinal products in accordance with applicable regulations and study-specific requirements.
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A Manufacturing and Import Authorisation (MIA) is required for the manufacture and import of medicinal products within the EU/EEA.
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A Qualified Person (QP) reviews and certifies batches before investigational medicinal products can be released for use in clinical studies.
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Yes. We support organisations in managing product defects, recalls and quality issues within clinical supply chains.
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Our Clinical QP services are designed for pharmaceutical companies, biopharmaceutical organisations and other organisations involved in clinical development.