Whitepapers

Whitepaper: Modernizing CMC Submissions

October 15, 2025

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A Whitepaper That Looks at How GenAI-Powered Automation Is Helping Teams Prepare for the Future of Regulatory Submissions

As regulatory scrutiny intensifies and global agencies push for digital-first submissions, Chemistry, Manufacturing, and Controls (CMC) documentation has become a high-risk area for delays and rejections.

With over 70% of recent FDA rejections linked to CMC issues, the time to modernize is now.

In this whitepaper, we explore how GenAI-powered automation solutions can help regulatory teams reduce risk, increase consistency, and accelerate time to market.

WHAT YOU’LL LEARN IN THIS WHITEPAPER:

Why the Quality Overall Summary (QOS) is a strategic entry point for automation
How the upcoming ICH M4Q(R2) guidance will reshape regulatory content strategy
What GenAI platforms like Yseop Copilot can do to reduce rework and improve submission speed
Real-world success stories showing dramatic time savings and ROI

What does this CMC whitepaper cover?

Why CMC delays now top the list of FDA rejections

How GenAI is transforming QOS drafting

What structured authoring means for your team — and how to start now.

Each day that a new drug or vaccine gets to market sooner, it creates $1-3 Million in accelerated revenue

It used to take us a minimum of 4 hours to write 1 patient narrative. Now, it takes 4 seconds to write an unlimited number of them.

We wanted to be certain and very accurate around what we produce in these documents that are submitted to health authorities. We want to deliver a draft through Artificial Intelligence that is 100% reliable and needs no further editing by human medical writers. That is what we have achieved with the Yseop collaboration.

Machine learning is a part of every aspect of Lilly’s future, from drug discovery to clinical trials to manufacturing to patient support. Yseop brings a novel approach to regulatory submissions and other reporting, and we see opportunities to bring Yseop’s technology to teams throughout the enterprise.