Yseop Unveils Roadmap to One-Click Dossier: Accelerating Scalable, Compliant Regulatory Writing

With 27,000+ reports generated per month, Yseop solidifies its leadership in regulatory automation ahead of its DIA 2025 showcase

NEW YORK, June 16, 2025 (GLOBE NEWSWIRE) -- Yseop, the global leader in Generative AI for life sciences, today announced the next phase in delivering its One-Click Dossier vision, a scalable automation approach designed to streamline regulatory document generation and reduce time-to-submission. This will be formally presented during Yseop’s Innovation Theater session at the DIA Annual Meeting on June 17 in Washington, DC.

The One-Click Dossier streamlines the production of high quality regulatory documents, such as Clinical Study Reports (CSRs), patient narratives, summaries, and others in a fully automated workflow. By eliminating manual steps from data ingestion to draft creation, Yseop empowers life sciences teams to generate compliant, submission ready documents with significantly less effort and greater accuracy.

“Highly regulated industries like BioPharma often require weeks of manual work to produce compliant clinical documents,” said Emmanuel Walckenaer, CEO of Yseop. “With these core capabilities, we’re helping teams accelerate document creation today and move toward a future where regulatory submission could be as seamless as a single click.”

How Yseop is Building Toward One-Click Submissions

Built to meet eCTD standards, the One-Click Dossier addresses core industry challenges, including redundant copy-paste work, inconsistent data reuse, and long review cycles that delay submissions and time to market. By intelligently automating the authoring process, Yseop’s Copilot platform helps ensure traceability, version control, and compliance from the start.

Instead of manually stitching together data, writers now have a streamlined experience where documents are automatically assembled from verified inputs using context aware templates and AI-based data transformation. These capabilities are foundational to Yseop’s One-Click Dossier vision — enabling regulatory teams to work more efficiently today, while progressing toward a future where submission generation could be near-instant and fully automated.

The Four Building Blocks of One-Click Dossier

Documents created with One-Click Dossier are not static snapshots. They remain dynamically linked to source systems, allowing updates until final data lock, ensuring documents evolve in parallel with study data. This capability reduces rework, improves accuracy, and supports a more responsive regulatory workflow. Yseop’s end-to-end automation is powered by four tightly integrated components:

• Direct Source Connectivity: Real-time integration with structured and unstructured data via Veeva Vault, Amazon S3, and other systems.
• AI-Powered Data Processing: Intelligent extraction, structuring, and mapping of reusable content from diverse formats including ARDs and RTFs.
• Automated Draft Generation: High-quality, submission-ready documents created in minutes, with full traceability from source to output.
• Dynamic, Compliant Templates: Templates dynamically adapt to study context, such as therapeutic area, phase, and population, ensuring regulatory alignment and minimal rework.

“This isn’t just an enhancement, it redefines how pharma teams approach compliance and scale,” said Walckenaer. “We’re equipping writers with the tools they need to focus on science, not formatting.”

Trusted by the Industry’s Leaders

The next phase of One-Click Dossier builds on significant enterprise momentum for Yseop’s Copilot platform, which supports some of the world’s largest pharmaceutical organizations, including Eli Lilly and Novartis. Yseop’s recent growth highlights include:

• Minimum 30–50% reduction in time spent on document creation, delivering faster turnaround for regulatory teams
• 2–3 weeks acceleration in submission timelines, helping bring treatments to market more quickly
• Study document volume has more than doubled year over year, showing deeper platform adoption across pharma teams.
• Average of 27,000+ reports generated each month, underscoring the platform’s enterprise-grade scale and reliability

Yseop at the DIA Annual Meeting in Washington, DC
Yseop’s Innovation Theater presentation on June 17 at 11:45am in Innovation Theater #2 will showcase the capabilities behind One-Click Dossier and offer a look at the future of AI-powered regulatory operations. To experience One-Click Dossier firsthand, visit Yseop at Booth 609 or explore more at yseop.com.

About Yseop

Yseop is the leader in Generative AI for regulated industries, changing the way content automation solutions are delivered with a human-centric, AI platform. Yseop is reimagining the future of scientific writing to get medicine into the hands of those who need it faster. With a suite of industry-specific applications and technology that blends symbolic, machine learning, and LLM techniques, Yseop ensures that even the most demanding content automation tasks are met with ease, scalability and application security across the entire enterprise.

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