regulatory-operations-transformation | KPMG United States
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Regulatory Operations Transformation

Regulatory Operations Transformation

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



KPMG in the U.S.


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The Regulatory Affairs organization is a key driver of the Life Sciences product life cycle.Regulatory Operations is the ‘backbone’ of this organization, with responsibility for managing regulatory submissions and the accompanying regulatory license, commitment and submission planning data on a global scale.

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

  • Continued expansion into emerging markets
  • Increasingly complex reporting requirements (e.g. IDMP)
  • M&A / divestitures
  • Innovative products

Many Life Sciences companies are investing in significant Regulatory Operations transformation programs. Our Life Sciences practice has the unique ability to combine broad operational and technology consulting experience with functional expertise in Regulatory Operations 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:

Transformation focus areas

What you get from KPMG

Our goal is to help our clients improve efficiency within their Regulatory Operations 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 maintenance activities.

We provide a wide range of services including current-state assessment, future-state design, technology implementation support, data collection and harmonization, program management, and change management.

Our Regulatory Affairs Capabilities

Regulatory Operations 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

Digital transformation in regulatory affairs
It is high time for life sciences organizations to use digital technologies to reimagine the regulatory affairs function. Automation and cognitive technologies hold enormous potential for not only improving the function, but also for driving continuous value for the organization. Read the thought leadership piece here.

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