In recent years, medicinal products for the EU market are increasingly manufactured outside the EU. Globalization has made supply chains more complex and EU regulations became more demanding in recent years.

If you want to import medicinal products into the EU, you need an EU import site with QP and GMP accreditation. Setting up such an entity is expensive in terms of investment in infrastructure, equipment, personnel, etc. By outsourcing these activities, you will have a clear picture of the costs upfront and will have access to our experts for QC, QP, and RA for importing medicines into the EU. QbD holds Manufacturer’s/Importer’s Authorisations (MIAs) for the importation and QP certification of both Commercial and Clinical products within the EU. Setting up and maintaining such an entity demands a deep understanding of EU pharmaceutical regulations, quality control (QC) standards, and the role of the QP in ensuring product quality and compliance. This complexity often leads organizations to explore alternative options to streamline the importation process and ensure compliance with EU regulations.

Outsourcing these activities to Quality by Design (QbD), that has expertise in the importation of medicinal products into the EU has several advantages:

• Cost Clarity: Outsourcing allows importers to have a clear and predictable understanding of the costs involved upfront. This transparency helps in budget planning and financial management.

• Access to Experts: Importers benefit from the extensive knowledge and experience of experts in QC, QP certification, and Regulatory Affairs (RA) specific to importing medicines into the EU. These experts navigate the intricate regulatory landscape, ensuring compliance at every step of the process.

• Manufacturer Importer Authorisations (MIA): QbD holds a MIA, essential for the importation and QP certification of both commercial and clinical products within the EU. This eliminates the need for importers to obtain these authorizations individually.

• Efficiency and Compliance: Outsourcing streamlines the importation process, enhances efficiency, and ensures compliance with EU regulatory requirements. It allows importers to focus on their core operations while experts handle the complexities of importation.

Interested in this offer?

Contact: Yves Peeraer - yves@quercus.be