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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.

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Accelerate the time
it takes to get
therapies to market
by 3+ months
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Quickly respond to
health authority
queries
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Standardize text outputs
to ensure consistent,
accurate, & compliant
writing styles

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Automation Benefits for
Regulatory Affairs Teams

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1.

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

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2.

Remove tedious administrative work like importing and transforming tables.
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3.

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

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

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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
Equipped with instant insights and impactful visuals and texts, our finance teams can now jump into the next generation of data analytics.
Hélène DoréGlobal Chief Transformation Officer for Finance & Legal, L'Oréal
Yseop enables us to focus our discussions on action plans for the branch. Now we spend more time talking about sales performance rather than analyzing figures. It saves time for myself and my team.
Branch DirectorFrench Multinational Retail Bank
The Yseop engine produces this commentary in less than a second. We are just scratching the surface with this technology.
Director, Global Process OwnerProduct Control at a Tier 1 US Bank
With Yseop, we give clear explanations to our customers. The customer understands the decision and I have more time to focus on other opportunities. It's a real innovation!
Client BrokerInternational Insurance Company
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Let’s start automating your data to narratives today!

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