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.
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).