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08 Sep 2026
4 minute read

M4Q(R2): A catalyst for more structured regulatory quality operations

A new quality submission structure is taking shape. The opportunity goes beyond compliance: it can help organisations manage quality information in a more structured, governed and lifecycle-ready way.

What the article covers

  • The article explains the key changes from M4Q(R1) to M4Q(R2) and how the revision fits into the wider regulatory modernisation landscape.
  • It explores how existing capabilities such as Regulatory Information Management (RIM) systems, master data management (MDM) capabilities and ISO IDMP / EMA SPOR can support readiness across different product portfolios.

The M4Q(R2) opportunity

Read our overview of what M4Q(R2) changes, how it fits into the wider regulatory modernisation landscape, and what organisations can already consider as they prepare.

Download the article

Why it matters

M4Q(R2) can become a practical trigger to improve how regulatory quality information is structured, owned, maintained and reused across the product lifecycle.

More structured information

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Stronger lifecycle control

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Foundations for the future

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From regulatory requirement to lifecycle advantage

Organisations do not need to wait for every regional detail to be defined before assessing where M4Q(R2) may affect their portfolio, processes, systems, and information foundations. Early preparation can create value beyond compliance by improving how quality information is structured, maintained, and reused across the product lifecycle.

Contributors

We thank Juliette Odorico and Zinnia Truan for their insights and contributions to the article.                                                                                                                                                                                                                                                                                                                                                                                                                                                                   

Get in touch

Kathy Tench

Kathy Tench

Partner
+41 58 279 9040
Robin Guettinger

Robin Guettinger

Manager
+41 58 279 90 36

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