Yseop Copilot for Life Sciences

Yseop Copilot for Life Sciences is an AI-powered regulatory and medical writing platform designed for pharmaceutical and life sciences organisations operating in highly regulated environments. Trusted by some of the world's largest pharma companies, including Lilly and Sanofi, Yseop Copilot automates the creation of regulatory and clinical documents—reducing drafting time from weeks to minutes while maintaining accuracy, consistency, and compliance throughout the submission process.

Recognised as a TIME Best Invention of 2025 in the Medical & Healthcare category and a two-time winner of the BIG Innovation Award, Yseop has pioneered automation in regulatory and medical writing for over a decade. The platform functions as an intelligent digital colleague, enabling regulatory, medical, and cross-functional teams to produce submission-ready documents at scale with confidence.

Core Capabilities

• Faster document generation: Produce regulatory and medical documents—including Clinical Study Reports (CSRs), patient narratives, and Quality Overall Summaries (QOS)—in minutes rather than weeks, dramatically reducing manual drafting effort.
• Accuracy and compliance at every step: Regulatory standards are integrated directly into the document creation process, automating compliance checks and minimising risk throughout the writing lifecycle.
• Seamless team collaboration: Structured workflows, real-time updates, and automated review processes break down silos and keep regulatory, medical, and cross-functional teams aligned.
• Scalable reporting: From clinical documentation to quality reviews, Yseop Copilot adapts to a team's unique workflows, delivering high-quality reports at scale across a wide range of reporting needs.
• Audit readiness and change tracking: Automated regulatory checks, tracked changes, and maintained audit trails ensure documents are submission-ready at every stage.

Key Workflow Benefits

• Cuts drafting time significantly—one Lilly scientific writing team member reported reducing patient narrative creation from a minimum of 4 hours per narrative to just 4 seconds for an unlimited number.
• Eliminates bottlenecks and manual rework through AI-driven workflows that streamline updates and reduce back-and-forth between teams.
• Delivers first drafts that are reliable and require no further editing by human medical writers, as validated in Yseop's collaboration with Sanofi.
• Accelerates time to market for new therapies—each day a drug or vaccine reaches market sooner is estimated to generate $1–3 million in accelerated revenue.
• Supports CMC submission modernisation, helping regulatory teams automate QOS drafting and stay ahead of ICH M4Q(R2) requirements to address the leading cause of FDA rejections.

Awards and Industry Recognition

• Named to TIME's Best Inventions of 2025 in the Medical & Healthcare category.
• Winner of the BIG Innovation Award for two consecutive years (2025 and 2026) for transforming regulatory writing with Generative AI.
• Gold winner at the 2024 Merit Awards for Best AI Product.
• 2024 finalist in the Business Intelligence Group's Artificial Intelligence Excellence Awards.
• Winner of the Global Generative AI Award in the Healthcare and Life Sciences category.

Yseop Copilot is purpose-built for the demands of highly regulated life sciences environments, with enterprise-grade scalability that has been validated by leading global pharmaceutical organisations. The platform supports teams across regulatory affairs, medical writing, and broader enterprise functions, enabling faster drug approvals and more efficient paths from clinical data to final submission.