API
manufacturer
Your product on the EU market
EU-GMP import →
Are you looking for EU-GMP Import services to support your business? The QbD Group is GMP licensed and can support all steps of importing your products, including QC and QP services.
Our legal entity is available to act as the formal marketing authorization holder for your medicinal product in any EU/EEA country. Moreover, our Regulatory Affairs experts can manage full CP/DCP/MRP/NP registration procedures on your behalf.
Marketing authorization is granted only to an EU-based applicant. Medicines imported into the EU must be QC tested and QP batch-released before entering the EU. Our QP and EU batch release services can assist you with EU imports of sterile and non-sterile medicinal products, as well as ATMP and IMP.
The QbD Group 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 as outlined below.
All medicines entering the EU must comply with EU-GMP standards.
The QbD Group 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 without the need of installing a local affiliate in the EU.
You will find all relevant expertise in one group and a single point of contact will be assigned to your project and products.
Don’t hesitate to contact us so we can listen to your needs and provide you with the right service. Once we receive a request for analysis, you will receive a detailed quote and a lead time for reporting the analysis results.
Come to see the QbD Group at stand #3G73 at CPHI Conference in Barcelona. And after the conference…Eat & Connect with lifescience professionals at our QbD’s CPHI Networking Drink.