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 demonstrated that the concepts of “Real Lean” are equally applicable and effective in Regulatory Affairs Operations and have developed a skill set capable of transforming Reg Ops groups into highly efficient, high quality, highly compliant and low cost operators.
This white paper discusses 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.