EU Import & QP batch release services
Looking for QP release or EU import services to support your business?
Quercus Labo has authorization for testing and release of medicinal products in accordance with EMA Directive 2001/83/EC.
Our own qualified persons (QPs) can certify the batch release testing, in accordance with Annex 16 of the EU GMP Guidelines.
Please do not hesitate to contact us for more information on our EU import & QP batch release services.
GMP Batch Testing & Release Batches
Formal marketing authorization holder
We can perform GMP batch testing and release batches for both sterile and non-sterile medicinal products, for human and veterinary use, as well as for Investigational Medicinal Products (IMP) used in clinical trials.
Companies wishing to import medicines can also turn to Quercus for EU product release. We provide EU import clearance responsibilities for companies outside the European Union, especially for manufacturers from countries without mutual recognition (MRA) who wish to import their products within the European Economic Area (EEA).
In these cases, batch tests are required before products are released.
For customers without a legal entity in the EU, Quercus Labo is available to act as the formal marketing authorization holder for your medicinal product in any EU/EEA country.
What can we do for you?
Our integrated service pack for GMP batch testing and batch release
- Analytical method transfer (AMT) or Analytical method validation (AMV)
- Batch testing and batch release of clinical or commercial batches
- Storing retention and/or reference samples
- Issuing QP Declarations for IMPs and marketed products
- Auditing manufacturing supply chain (EU-GMP compliant partner)
- Managing quality agreement
- Reviewing batch documents and transport conditions
- Managing out-of-specification, change control, deviations and CAPAs
- Batch manufacturing and packaging records review
- Batch release in accordance with Marketing Authorisation
- Marketing Authorisation (MA) holder services
- Regulatory services
- Ongoing stability studies