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Welcome to Yseop Copilot

Completely reimagine your regulatory documentation processes

With Yseop Copilot, the world’s top pharmaceutical companies have automated document creation for a seamless drafting experience. 

Regulatory Document Coverage Across eCTD Modules

Where does Yseop Copilot drive impact
in medical and regulatory writing?

1.

DRAFTING 

Precise and Accurate Regulatory Documents

  • Accelerate document creation
  • Ensure consistency and compliance
  • Streamline data integration
  • Experience seamless drafting in Microsoft Word & Veeva Vault
  • Support tailored outputs

2.

AUTHORING

Continuous Updates and Validation

  • Enable early authoring
  • Streamline updates and validation
  • Finalize and lock sections incrementally
  • Automate data-driven content
  • Simplify change management
  • Accelerate readiness across documents

3.

FINALIZING

QC, Review Cycles, & Final Submission

  • Eliminate manual QC tasks
  • Streamline review cycles 
  • Ensure full traceability and audit readiness
  • Enhance data integrity & grammar consistency
  • Accelerate final submission with minimized last-minute changes

Ready to deploy, ensuring rapid and successful implementations

With one-click draft generation in Microsoft Word, medical writers can work where they are comfortable. Access a unique generative AI platform for regulatory document generation to scale capacity, retain employees, and improve report quality.
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

Automate core regulatory documents across the clinical trial process

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)

Preclinical

• PK (Pharmacokinetic)

An ecosystem of strategic partners supports an end-to-end approach for the content authoring journey

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.

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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