Acting as an external Qualified Person (QP) we assume responsibility for batch release of medicinal products and IMPs.
We also take care of EU import release responsibilities for companies outside of the European Economic Area. We monitor (contract) manufacturing and ensure that quality management according to Good Manufacturing Practice (GMP) requirements are met.
Batch release services
Batch release for medicinal products in compliance with Good Manufacturing Practice (GMP) requirements and for medical devices
Release of medicinal products for clinical trials (investigational medicinal products)
Batch release for medicinal products with special requirements such as … vaccines, narcotic drugs and genetically engineered pharmaceuticals
QP-certified batch release analysis
Import release for medicinal products from companies outside of the EU / EEA