Our QM department therefore performs numerous quality assurance tasks for the development projects – both after receiving approval, during the launch and in the commercialisation phase.

This includes incident management and transfer of information for complaints, deviations and OOS handling, product or process changes between customers, WELDING and manufacturers as well as comprehensive supplier qualification for all manufacturers and service providers, including laboratories and auditors. We provide comprehensive support to our partners and clients in auditing manufacturers, conducting PQRs and auditing batch documentation, routine auditing of master batch records, OGS data and ICH Q3D risk assessments.

Here, our licensees benefit in comparison to possible in-house developments: Costs, for example for audit reports and PQR, can be distributed among several parties.