The Danish Medicines Agency (DMA) recently changed its practice to pre-approve contract manufacturers and contract laboratories acceptors.
However DMA mentions a few pre-requisites which need to be considered:
This will be monitored by DMA by random checks and by an updated list of contract acceptors that should always be available at the company. This list must contain defined information about the contract acceptor, the respective audits and the contract itself.
Source: DMA News
CONCEPT HEIDELBERG (a service provider entrusted by the ECA Foundation)