Batch release for medicinal products
Diapharm takes responsibility. Acting as an external Qualified Person (QP) we assume responsibility for batch release of medicinal products.
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 (e.g. ebola), narcotic drugs and genetically engineered pharmaceuticals
- QP-certified batch release analysis
- Import release for medicinal products from companies outside of the EU / EEA
- Assuming responsibility as a QP
This batch release service offers companies the option of placing medicinal products with a marketing authorisation on the market without the need to establish a new or modify an existing QM system or to hire a Qualified Person. Our Hälsa Pharma service provides clients with a complete quality management system that is certified according to GMP (Good Manufacturing Practice).