BSM have been pioneering applied research into the utilization of "Real Lean" methodologies to solve problems and generate efficiencies in Regulatory Affairs Operations (Reg Ops) in large life science companies. Operations from a Regulatory perspective encompasses the standard activities that accompany the filing of Regulatory submissions such as Labelling, Publishing, Production, Archiving etc. "Real Lean" is the term used to describe BSM's approach to implementing Lean in a wide variety of industrial settings. "Real Lean" has at its core a commitment to incorporate the key principles of Levelling, Flow and Standard Work as a basic operation system.
BSM have just published a White Paper entitled 'Lean in Regulatory Operations'. Co-authors of the report are Dr Alan Maloney, Consultant at BSM and Dr Gary Ryan, Operations Service Manager. The white paper addresses the many issues that a Lean Project Team is likely to encounter in the Regulatory environment. It also outlines the key elements of BSM’s “Real Lean” solution to address these issues.
Download 'Lean in Regulatory Operations' White Paper.