Supporting pharmaceutical import and market access
Importing and distributing pharmaceutical products within the EU/EEA involves far more than logistics alone. Organisations must comply with strict regulatory requirements covering quality, batch certification and market access. This is where Qualified Person (QP) services play a critical role.
Normec supports pharmaceutical and biopharmaceutical organisations with licensing, quality systems and Qualified Person services for both investigational and commercial medicinal products.
From import programmes to batch certification, we help organisations establish compliant, efficient and well-controlled processes.
Licences, batch certification and audits
Pharmaceutical supply chains rely on multiple interconnected processes that must operate seamlessly. That is why we provide specialist QP services and practical support throughout complex projects.
Our services include:
- QP services for commercial medicinal products
- EU import and distribution support
- Marketing Authorisation (MA) filing support
- Virtual Marketing Authorisation Holder (virtual MAH) services
- Support with MIA and WDA licences
- QP audits and quality audits
- Batch certification and batch release
We ensure your processes comply with current EU/EEA regulations and the expectations of regulatory authorities.
Building a reliable supply chain
Within the pharmaceutical industry, compliance is about more than documentation. Processes must work effectively in practice while minimising delays and reducing supply chain risks.
Our Qualified Persons work closely with quality, operations and supply chain teams to improve efficiency and strengthen process control. We also provide support with quality assurance, deviations, recalls and inspection readiness.
With our support, you can:
- Streamline batch certification processes
- Strengthen compliance throughout import and distribution activities
- Improve supply chain risk management
- Be fully prepared for audits and inspections
- Accelerate market access within the EU/EEA
Expertise in QP services and quality assurance
QP services require up-to-date knowledge of pharmaceutical regulations, quality systems and manufacturing processes, particularly in international supply chains involving multiple sites, suppliers and stakeholders.
Our specialists have extensive experience in the pharmaceutical and biopharmaceutical sectors and understand how quality, supply chain management and regulatory compliance come together in daily operations.
Whether you require support with batch certification, QP declarations, audits or licensing programmes, we provide solutions that are both practical and fully aligned with regulatory requirements.
Supporting growth in international supply chains
International distribution, evolving regulations and increasingly complex supply chains require organisations to remain flexible and responsive. By combining QP expertise, quality assurance and practical support, we help organisations achieve safe and reliable market access throughout the EU/EEA.
Together, we build resilient supply chains that are ready for future challenges.
Would you like to know more about QP services?
Frequently Asked Questions
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QP services focus on quality assurance, batch certification and regulatory compliance within pharmaceutical import and distribution.
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A Qualified Person is responsible for certifying and releasing pharmaceutical batches in accordance with European pharmaceutical legislation.
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Batch release is the process of verifying that a product meets all quality and regulatory requirements before it is released to the market.
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These licences are required for pharmaceutical manufacturing, import and distribution activities within the EU/EEA.
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Yes. We support organisations with QP audits, quality audits and inspection readiness.
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A virtual Marketing Authorisation Holder (MAH) service enables Normec to support organisations as a virtual licence holder throughout regulatory and compliance processes.
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These services are designed for pharmaceutical, biopharmaceutical and healthcare organisations involved in import, distribution and market access.