Batch release for medicinal products and medical devices
Diapharm takes responsibility. Acting as an external “qualified person”, we assume responsibility for batch release of medicinal products or act as a releasing manufacturer for medical devices. We monitor (contract) manufacturing and ensure that quality management and Good Manufacturing Practice (GMP) requirements are met. We also take care of EU import release responsibilities for companies outside of the European Economic Area.Our services include:
- Batch release for medicinal products according to GMP or "Good Manufacturing Practice" requirements and for medical devices
- Release of medicinal products for clinical trials (investigational medicinal products)
- Import release for medicinal products from companies outside of the EU / EEA
- Assuming responsibility as a manufacturer as defined in article 1, 2(f) of the Medical Devices Directive (93/42/EEC)
This batch release service offers companies the option of placing medicinal products and medical devices on the market without having to establish their own QM system or making costly modifications. Our HÄLSA Pharma service provides clients with a complete quality management system that is certified according to GMP (Good Manufacturing Practice), ISO 9001 (QM systems) and ISO 13485 (medical devices).
