Right first time | vast equipment infrastructure | FMEA risk assessments | CPP classification | model support DoEs | PARs | design space builds | source documentation | data transfer in real-time
The closer a process gets to the patient the harder we work together to ensure that your life-changing medicine can be introduced to manufacturing right first time. We combine a vast equipment infrastructure, with tools to characterize processes completely and a team who understand how processes run in real manufacturing scenarios.
Together we conduct FMEA risk assessments, CPP classification, model supported design of PARs and DoEs to fully characterize late-stage processes as they are prepared for commercial introduction. The depth of knowledge collected and collated across process, analytical, modeling and scale-up sciences becomes the platform for manufacturing introduction and is essential for lab model development, design space builds and the provision of source document to the regulators for demonstrating knowledge of your manufacturing control strategy.
Our clients are never kept in the dark when they work with us and we return every data point in real-time so that you can lock in process parameters quickly and conduct tech transfer transparently. We seek to provide clarity when you most need it, as you take your medicine to the market.