QP release and EU import
Are you looking for QP release or EU import services to support your business? Quercus – part of the QbD Group – holds a GMP license for batch release.
Quercus’ legal entity is available to act as the formal marketing authorization holder for your drug in any EU/EEA country.
Together with QbD’s regulatory affairs experts, we are able to manage complete CP/DCP/MRP/NP registration procedures on your behalf.
Don’t hesitate to contact us for more information about our QP or import services.
Parte de QbD Group
Este servicio está respaldado por Quercus
What are QP and EU batch releases?
A marketing authorization is granted only to an applicant located in the EU. Medicines imported into the EU must be QC-tested and QP batch-released before entering the EU.
Quercus’ QP and EU batch release services can help you with EU imports of sterile and non-sterile medicinal products, as well as iATMP and IMP.
Why QbD Group?
All medicines entering the EU must comply with EU GMP standards.
Quercus has a GMP license, is inspected by the Belgian FAGG, and serves many customers from outside the EU with the QP, QC, and regulatory EU import of their medicines.
We can assist you with all regulatory, QC, and QP questions and ensure that you continue to meet the expectations of EU GMP and local legislation.
Manufacturers and importers can rely on QbD and Quercus without the need of installing a local affiliate in the EU.
Outsourcing your QP and EU import
Quercus can assist you with a single QC or regulatory question, but we can also take over the entire process of registration of your medicines in the EU, QC analysis, import, and batch release.
Once we receive a request for analysis, you will receive a detailed quote and a lead time for reporting the analysis results.
Contact us
Don’t hesitate to contact us so we can listen to your needs and provide you with the right service.
