AI-Powered Regulatory Writing – From First Draft to Final Submission

Accelerate regulatory documentation with automation that reduces drafting time, increases team capacity and ensures compliance.

RECOGNIZED AMONG 300 INNOVATIONS

YSEOP NAMED TO TIME'S BEST INVENTIONS OF 2025

TIME has named Yseop Copilot one of the Best Inventions of 2025 in the Medical & Healthcare category. This honor underscores our leadership in AI-powered automation and our commitment to helping clients bring therapies to market faster.

For over a decade, Yseop has pioneered automation in regulatory and medical writing—long before AI became mainstream. Our technology is trusted by the world’s largest pharma companies to accelerate document creation while ensuring compliance and quality.

AI That Works Like Your Best Medical Writer—At Scale

Generate Accurate and Compliant Documents

Cut drafting time from weeks to minutes while ensuring accuracy and consistency across CSRs, patient narratives, and more.

Eliminate Bottlenecks and Manual Rework

AI-driven workflows streamline updates, reduce back-and-forth, and enable teams to collaborate seamlessly.

Ensure Compliance from Start to Submission

Automate regulatory checks, track changes, and maintain audit readiness—delivering submission-ready documents with confidence.

HOW REGULATORY TEAMS ARE MODERNIZING CMC SUBMISSIONS

CMC issues now drive most FDA rejections. This whitepaper shows how GenAI helps regulatory teams automate QOS drafting, stay compliant, and get ahead of ICH M4Q(R2).

Yseop Copilot for Life Sciences

Intelligent Document Creation, Collaboration, and Compliance

1. Faster, More Efficient Document Generation

Produce regulatory and medical documents in minutes, not weeks. Ensure consistency, accuracy, and compliance while reducing manual effort.

2. Seamless Collaboration Across Teams

Break silos with structured workflows, real-time updates, and automated review processes—enabling regulatory, medical, and cross-functional teams to stay aligned.

3. Accuracy and Compliance at Every Step

Integrate regulatory standards directly into document creation, automating compliance checks and minimizing risk.

4. Scalable for a Range of Reporting Needs

From clinical documentation to quality reviews, Yseop Copilot adapts to your team’s unique workflows—delivering high-quality reports at scale.

Your Automated Medical Writing Journey Starts Here.

See how Yseop Copilot eliminates inefficiencies, enhances compliance, and accelerates approvals—so you can bring treatments to market faster.

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.