Regulatory Document Automation

Collapse the database lock to filing timeline and get life saving therapies to market faster

By producing the first drafts of regulatory documents through automation, teams have a unique opportunity to accelerate getting medicines to patients faster without compromising on quality.

Yseop Copilot automates core regulatory report documents across the eCTD pyramid to dramatically accelerate submission timelines.

Accelerate the time it takes to get therapies to market by 3+ months

Quickly respond to health authority queries

Standardize text outputs to ensure consistent, accurate, and compliant writing styles

Automation Benefits for Regulatory Affairs Teams

Work more efficiently and sustainably to deliver accelerated submissions while maintaining high writing standards.

Remove tedious administrative work like importing and transforming tables.

With regulatory teams under tremendous pressure to collapse submission timelines, reduce your development costs and cycle times securely.

Automate core regulatory documents across the clinical trial process

Clinical

Discover how our AI-based, natural language generation (NLG) platform accelerates the time it takes for drugs to get to market and eliminates the risk of human error in the data review process.

• 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

Yseop Copilot’s automation packs automate the critical chain of preclinical documents to deliver a comprehensive level of report automation for highly accurate narratives.

• PK (Pharmacokinetic)

Clinical

Discover how our AI-based, natural language generation (NLG) platform accelerates the time it takes for drugs to get to market and eliminates the risk of human error in the data review process.

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

Yseop Copilot’s automation packs automate the critical chain of preclinical documents to deliver a comprehensive level of report automation for highly accurate narratives.

PK (Pharmacokinetic)

The benefits of Generative AI for Pharma

Move document development upstream to accelerate downstream

30-50% reduction in authoring time and 2-week acceleration from DBL

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.

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.

Each day that a new drug or vaccine gets to market sooner, it creates $1-3 Million in accelerated revenue

Talk to One of Our Experts

Let’s start automating your data to narratives today!