Regulatory-grade AI for submission-ready documents
Yseop generates regulatory documents you can defend under audit. Built for accuracy, traceability, and repeatability in GxP-regulated environments.
Trusted by life sciences and regulatory teams worldwide
AI that works
AI you can trust under regulatory review
Content generation is easy. Getting content approved is not. Most AI tools stop at drafting. Regulatory teams need content that is grounded, traceable, and consistent across submissions.
Generate
Create submission-ready drafts from structured and narrative data. Ground every draft in source data from the start.
Align
Coordinate drafting, validation, and review across teams. Update once. Apply everywhere—across documents and submissions
Control
Work directly in Microsoft Word and connect with Veeva Vault. Built-in traceability, audit trails, and QC checks for inspection readiness.
Us VS Them
How Yseop compares
See why teams choose Yseop over other AI tools
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Competitors Others | |
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Accurate — not just generated
Grounded in your source data and validated against regulatory rules and templates
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Traceable — every claim accounted for Every sentence is linked to its source from the start Full audit trail — ready for inspection at any time |
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Built for GxP environments Designed and validated for regulatory requirements—not adapted after the fact |
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Proven in production Deployed across Top 10 global pharma companies. Used in 300+ clinical trials. Submissions approved by FDA and EMA. |
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Human control at every step AI executes. Your team reviews, validates, and approves |
Why Yesop
Why top 10 global pharma companies chose Yseop
Yseop is trusted by the world’s leading life sciences organizations because it generates content they can stand behind—and submit with confidence.
- Grounded in source data from the start
- Fully traceable for audit and inspection
- Consistent across documents and submissions
Automation
Automate Regulatory Documents from Data to Submission
Our AI-powered NLG platform speeds up drug market timelines and eliminates human error in data review.
Product truth
From Raw Data to Structured, Compliant Content
Yseop transforms structured datasets into fully formatted regulatory documents—ensuring consistency, traceability, and compliance across every output.
From Raw Data to Structured, Compliant Content
Yseop transforms structured datasets into fully formatted regulatory documents—ensuring consistency, traceability, and compliance across every output.
Direct Database Integration
Connect to SDTM, ADaM, and clinical data repositories without manual data extraction.
Neurosymbolic Processing
AI understands regulatory structure and clinical context, not just text patterns.
Automated Quality Validation
Every sentence validated against source data with complete audit documentation.
Testimonials
What Our Clients Are Saying
“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 
"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 
FAQ
Curious about something?
What to know before using AI in regulatory submissions
Regulatory-grade AI is designed for GxP-regulated environments, where every document must be accurate, traceable, and consistent.
Unlike general-purpose AI, it includes built-in validation, audit trails, and controls to support regulatory review and submission.
Most AI tools generate text. Yseop generates content that is:
- Grounded in source data
- Fully traceable for inspection
- Consistent across documents and submissions
It is built specifically for regulatory workflows—not adapted from generic AI.
Yes—if it meets regulatory standards.
Yseop is used in production by top global pharma companies and has supported submissions approved by FDA and EMA.
Every output is validated, traceable, and reviewed by your team before submission.
Yseop combines data-driven generation with built-in validation:
- Content is generated from structured and source data
- Outputs are checked against regulatory rules and templates
- Full audit trails ensure traceability and inspection readiness
Talk to One of Our Experts
Let’s start automating your data to narratives today!
Recognized Excellence
Recognized Excellence
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