While recent FDA guidance speaks to the agency’s support of innovative trial designs—including the use of external ...

Defining combination product CQAs across drug and device enables an end-to-end control strategy that improves product quality ...

Scale-up involves increasing pump sizes, reactor volumes, and flow rates—but the process control logic and system ...

Medical device design and development is a process that helps to ensure devices that go to market are safe, effective, marketable, and profitable. The process is a blueprint of the phases needed to ...