Regulatory Affairs Services for Life Sciences

Regulatory Affairs Services for Life Sciences

Reduce compliance risk and enable a smart, sustainable approach to regulatory activities.


Market forces and regulatory changes are increasing the pressure on Life Sciences companies to transform their Regulatory Affair Functional Activities.  Some of these triggers for change include:

  • Global operating models requiring seamless collaboration within regulatory teams
  • Increasing complex data and reporting requirements
  • M&A / divestitures
  • Innovative products

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.  We have experience assisting clients in the following functional service areas and capabilities:

Regulatory Affairs Focus areas

Regulatory Affairs Focus areas

What you get from KPMG

Our goal is to help our clients improve efficiency within their Regulatory Affrairs 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.


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.

Thought Leadership

Medical device regulatory affairs operational transformation
Key insights and opportunities to unlock additional value by streamlining Regulatory Affairs operational activities. Find the result of our industry survey and insights here.

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