With flexible GMP facilities and experienced teams, we support API commercialization through optimized process demonstrations and validation batches, ensuring successful regulatory submissions.
Eurofins CDMO provides impurity control strategies from IND to commercial stages. With a proven track record in impurity fate and purge studies, we analyze the origin, clearance, and fate of impurities to meet client requirements.
We provide comprehensive services throughout the development process, specializing in impurity synthesis and control. We identify, isolate and synthesize process-related impurities to support development, analytical controls and regulatory requirements.
Provided as part of an existing program or a stand-alone service, our commercialization support encompasses optimized process demonstration, Design of Experiments (DoE), critical process parameters studies including Quality by Design (QbD) and technology transfer to client’s API CMO, as applicable and continuous CMC support during and after market launch. We also prepare and execute process validation batches and commercial re-supply up to 1kg.