Project Management - API

The challenge:
To create GMP materials for safety studies.

Our role:
We drew up strategies for API production. Based on our extensive knowledge in upscaling organic chemistry and knowledge of the relevant GMP requirements, we identified a number of CMOs and CROs. We evaluated the bids based on a quality and cost perspective. Synthesis, stability testing and analysis were contracted out according to the designed specifications. Conditions were negotiated.

The result:
We have negotiated a plan that will ensure fast and flexible delivery, with clear stop/go points specified so that high costs can be rescheduled in order to balance project risks. We will shortly be auditing the CMO. API production will start shortly thereafter.