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Welcome to Yseop Copilot

Automate compliant document generation across clinical, safety, and CMC workflows—directly in Microsoft Word and Veeva Vault.

Yseop Copilot is the most advanced regulatory writing platform, streamlining everything from narrative generation to final submission. Built for scale, Copilot supports the world’s top life sciences teams.

Regulatory Document Coverage Across eCTD Modules

Regulatory Document Coverage
Across eCTD Modules

Clinical

  • Clinical Study Report (CSR)
  • Clinical Trial Narrative (CTN)
  • Summary Clinical Safety (SCS)
  • Summary Clinical Efficacy (SCE)
  • Investigator’s Brochure (IB)
  • Informed Consent Form (ICF)
  • Statistical Considerations Plan (SCP)
  • Lay Summary

Preclinical & CMC

  • PK (Pharmacokinetic)
  • Quality Overall Summary (QOS)

Where Yseop Copilot drives impact
in regulatory writing

1.

DRAFT

Accurate, Source-Driven First Drafts

  • Create fully formatted documents from structured and narrative sources

  • Draft directly in Microsoft Word and Veeva Vault

2.

AUTHOR

Live Updates and Reuse at Scale

  • Lock sections, reuse content, and validate against source changes

  • Automate updates across documents, templates, and regions

3.

FINALIZE

Ready for Submission in Fewer Cycles

  • Built-in QC, audit trails, and formatting

  • Assemble full dossiers for compliant eCTD delivery

Built for Seamless Deployment

With one-click draft generation directly in Microsoft Word, regulatory writers work in familiar environments while scaling their document production. Yseop Copilot helps life sciences teams improve report quality, retain talent, and meet deadlines with confidence.

Yseop Copilot Capabilities
1
World class SaaS security and access control with GxP compliance
2
Reflect modern data submission processes used by health authorities
3
Microsoft Word plug-in to work where writers are comfortable
4
Flexible document coverage with a configurable studio, no code required
5

Documents that match customer templates and submission standards

6
Multimodal approach using LLMs

A Strategic Ecosystem to Power Every Stage of Authoring

Yseop Copilot integrates seamlessly with the platforms your teams already use, enabling a fully connected and compliant regulatory workflow—from kickoff to final submission.

Key Partner Integrations

Yseop’s strategic partner network offers users a streamlined and automated approach to authoring. From document management to final publishing for each submission country and region, teams have access to an ideal writing management workflow.
Each day that a new drug or vaccine gets to market sooner, it creates $1-3 Million in accelerated revenue
Tim ColemanCIO of Medicine Development, Lilly
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.
Scientific Writing Team MemberLilly
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.
Laetitia MarosseroDomain Lead and Wearables, Sanofi
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.
Diogo RauSenior VP & Chief Information and Digital Officer, Lilly

Talk to One of Our Experts

Let’s start automating your data to narratives today!

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