Automate Medical & Regulatory Authoring Workflows

Empowering the world’s top BioPharma companies with pre-trained generative AI models.

Automate content outputs for key regulatory documentation and medical writing workflows. Increase productivity and get therapies to market faster.

Regulatory Document Coverage Across eCTD Modules

Preclinical

Deliver highly accurate narratives by automating parts of the preclinical document review cycle.

Clinical

Generate core elements of specialist medical reports, including clinical study reports (CSR) and patient narratives.

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

DRAFT

Generate 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

AUTHOR

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

FINALIZE

Optimize 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

Yseop Copilot is 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

World class SaaS security and access control with GxP compliance

Reflect modern data submission processes used by health authorities

Microsoft Word plug-in to work where writers are comfortable

Flexible document coverage with a configurable studio, no code required

Documents that match customer templates and submission standards

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)

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

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

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.

Talk to One of Our Experts

Let’s start automating your data to narratives today!