Process Development Planning

DHC’s process analyses

A common roadblock in interactions with the FDA, potential pharmaceutical partners/investors and upon tech transfer to a CMO is that no sponsor fully understands the process. DHC’s process analyses will rectify that

Processes are rigorously broken down into Unit Operations, each with a defined input & output, equipment, materials and tests and/or process controls

Unit Operations are connected to form standardized Process Flow Diagrams (PFD), which provides a framework for many purposes: cost analysis, regulatory submissions, technology transfers, and multivariate analysis of process performance.