QP service for
release analytics and EU retests
We hold a manufacturing licence for the release of pharmaceuticals in accordance with Section 13 (1) of the German Drugs Act (AMG). Upon request, our Qualified Persons (as defined in Directive 2001/83/EG) will certify the completed release testing for reference in accordance with Annex 16 of the EU GMP Guidelines in an officially recognised form.
Our standardised and transparent batch certification processes provide assurance for our clients that they have met official requirements, while clearly setting out responsibilities and defining interfaces.
QP services and release testing
We offer release testing and release analytics with QP certification for active substances, drug batches and products governed by the German Narcotic Drugs Act (BtMG) such as cannabis-based therapeutics.
Our release tests and EU retests enable pharmaceuticals manufacturers based outside the EU to obtain an import licence for the EU market.