iATMP QP batch release
Are you looking for a GMP-certified laboratory with qualified individuals to certify your ATMP?
Quercus – part of the QbD Group – is GMP-licensed for batch release and can certify your cell therapy product.
Don’t hesitate to contact us for more information about our iATMP QP batch release services.
What is iATMP QP batch release?
In the European Union, it is mandatory to have batches certified by a Qualified Person.
Quercus can be your certification site to release your batch in the European Union according to European and national legislation.
In addition, Quercus is able to assist you with any regulatory questions you may have and ensure that you remain in line with EU GMP and local legislation expectations.
Together with QbD’s regulatory affairs experts, we are able to provide complete registration procedures for your clinical trial.
Why QbD Group?
All ATMP 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 ATMPs.
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 QP affiliate in the EU.
Outsourcing your iATMP QP batch release
Quercus can act as a certification site or a Qualified Person can be at your site to certify batches.
Once we receive a request for support, you will receive a detailed and tailor-made quote and work order.
Don’t hesitate to contact us so we can listen to your needs and provide you with the right service.