Real Lean Transformation

Lean RA

Read what our consultants have to say about Real Lean in Regulatory Affairs (RA). For further information please contact us. 

Labelling Updates in Regulatory Affairs: Is product specific dedication of resources a good idea?

Managing changes to the content and format of product labelling is a key function within any Regulatory Affairs Organisation. Such functions are typically structured by therapeutic area, where each provides support for a reasonably small group of specific products. Read more about Labelling Updates in Regulatory Affairs: Is product specific dedication of resources a good idea?

Lean in Regulatory Operations

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. We use this term to distinguish our approach from generic Lean implementations which primarily focus on elimination of the seven wastes. “Real Lean” has at its core a commitment to incorporate the key principles of Levelling, Flow and Standard Work as a basic operating system.  Read more about Lean in Regulatory Operations