EU-GMP import and batch release
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.
EU-GMP import →
What does our EU-GMP import service entail?
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.Â
API manufacturer audit
- API manufacturer audit
- CAPA plan follow-up
- QP declaration
Finished product manufacturer
- EU-GMP readiness audit
- CAPA plan follow-up
- Regulatory strategy
- Dossier writing
EU-import warehouse & sampling
- GMP warehouse
- Distribution
- Sampling
QC analysis
- Method transfer
- Method Validation
- Routine analysis
- Ongoing stability studies
- Elemental Impurities
Go-to-Market
Why QbD Group?
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.
Contact us
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.
