Manufacturing Site Consolidation

Scoping and Managing the Regulatory Implications

A Kinapse best practice guide for global life sciences firms
Written by Stuart Goodall and Niamh Panesar

Executive summary



Continued high levels of industry churn through mergers, acquisitions and portfolio swaps create an ongoing need to streamline operations. Operational reviews provide a chance to increase capacity or rethink ownership.

Yet in operational restructuring it’s easy to underestimate the planning requirement, especially in relation to legal, technical and regulatory activities. Regulatory affairs departments will have so many other priorities vying for their attention that they may lack the capacity to assess and manage the regulatory implications of site transfers to the degree that is needed.

Based on Kinapse’s considerable experience of managing the regulatory aspects of manufacturing site consolidation, we have created this guidance document as a checklist of considerations.




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Our leadership team have watched the life Sciences industry develop and have a joint vision of how to push it forward. They challenge us to create better results for our clients, to come up with ways to revolutionize the industry and to redefine our place in it.

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Our leadership team have watched the life Sciences industry develop and have a joint vision of how to push it forward. They challenge us to create better results for our clients, to come up with ways to revolutionize the industry and to redefine our place in it.