Regulatory Affairs Services for Life Sciences

Transform regulatory operations: Reduce compliance risk and enable a smart, sustainable approach.

What you get from KPMG

Our goal is to help our clients improve efficiency within their Regulatory Affairs function by implementing process and technology changes. These transformational changes help Life Sciences companies bring products to market more quickly, while reducing compliance risk and enabling a sustainable approach to regulatory activities.

Many Life Sciences companies are investing in significant Regulatory Affairs transformation programs. Our Life Sciences practice has the unique ability to combine broad operational and technology consulting experience with functional expertise in Regulatory Affairs to help drive these programs. Our team can support initial assessments through to execution, with a persistent focus on solving our clients’ complex problems.

Business and operations consulting

  • Operating model and process re-design
  • Support preparing for regulatory mandates
  • Support for compliance remediation activities
  • Regulatory strategy enablement
  • M&A and divestitures – pre & post deal support
  • Data quality programs
  • Program management
  • Change management


Technology/digital enablement

  • Technology roadmap and solution selection
  • Business requirements definition
  • Design of supporting processes, including data entry model and governance
  • Global data collection/harmonization
  • Cross-functional integration design
  • Business scenario testing and UAT support
  • Development of digital/automation tools for specific Regulatory use cases

Our Regulatory Affairs capabilities

Regulatory Affairs Transformation – KPMG provides a range of services including current state assessment, future state design, technology implementation support, data collection and harmonization, program management and change management. Please click below to learn more about our Regulatory Affairs capabilities:

Contact us

Brian Williams

Brian Williams

Managing Director, Life Sciences Advisory, KPMG US

+1 312-995-3582
Rajesh Misra

Rajesh Misra

Principal, Life Sciences Advisory, KPMG US