Regulatory-Grade AI for Submission-Ready Content

Create regulatory documents with built-in accuracy, full traceability, and human control.

Most AI Can Generate Content. It Cannot Pass Regulatory Review.

Content generation is not enough for regulatory submissions. They require:

Accuracy grounded in source data, not assumptions
Full traceability from data to sentence, ready for audit
Consistent, repeatable output across every document

Yseop is built for what comes after draft generation: regulatory review, audit, and approval.

RECOGNIZED AMONG THE WORLD'S MOST IMPACTFUL INNOVATIONS

A TIME BEST INVENTION OF 2025

Yseop was named to TIME’s Best Inventions of 2025 in the Medical & Healthcare category, recognizing a new standard for AI in regulatory workflows and accelerating the path from data to submission.

How Yseop Delivers Submission-Ready Content

Accuracy — Grounded in Source Data

Validated against regulatory rules and templates, with less than 7% of content requiring re-authoring (GSK CSR).

Traceability — Every Claim Accounted For

Every sentence is linked to its source from the start, with a full audit trail ready for inspection.

Repeatability — Consistent Across Every Submission

Consistent output across documents, teams, and submissions. Update once, propagate everywhere without breaking approved content.

Built for Real Regulatory Workflows

Works directly in Microsoft Word, fitting into your document flow

Integrates with Veeva Vault and your existing infrastructure

Lock, reuse, and scale approved content across documents and submissions

Review, validate, and approve every output, nothing moves forward without you

AI executes. Humans decide.

Every output is validated, traceable, and approved by your team, because in regulatory submissions, accountability cannot be automated.

THE NEXT STANDARD FOR AI IN LIFE SCIENCES

The real challenge is not if AI can generate. It is whether that output can be trusted. Achieving regulatory-grade reliability requires a different architectural approach. This is where neuro-symbolic AI becomes critical—and increasingly unavoidable.

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.