Yseop

Yseop is an AI-powered regulatory and medical writing platform purpose-built for the life sciences industry. For over a decade, Yseop has pioneered intelligent automation in regulatory documentation—long before AI became mainstream—and is trusted by the world's largest pharmaceutical companies to accelerate document creation while ensuring compliance and quality. Named one of TIME's Best Inventions of 2025 in the Medical & Healthcare category, Yseop empowers regulatory, medical, and cross-functional teams to move from first draft to final submission faster and with greater confidence.

Yseop serves highly regulated life sciences organizations, including global biopharma leaders such as Eli Lilly and Sanofi. Its flagship product, Yseop Copilot, functions as an AI-powered digital colleague that automates the generation of complex regulatory and medical documents—reducing drafting time from weeks to minutes and enabling teams to scale their output without sacrificing accuracy or compliance.

Yseop Copilot – Core Capabilities

• Faster Document Generation: Produces regulatory and medical documents in minutes rather than weeks, ensuring consistency, accuracy, and compliance while significantly reducing manual effort. For example, patient narratives that previously took a minimum of four hours to write can now be generated in four seconds at unlimited scale.
• Seamless Team Collaboration: Breaks down silos with structured workflows, real-time updates, and automated review processes, keeping regulatory, medical, and cross-functional teams aligned throughout the document lifecycle.
• Built-In Compliance and Accuracy: Integrates regulatory standards directly into the document creation process, automating compliance checks, tracking changes, and maintaining audit readiness to deliver submission-ready documents with confidence.
• Scalable Reporting: Adapts to a wide range of reporting needs—from clinical documentation such as Clinical Study Reports (CSRs) and patient narratives to quality reviews and CMC submissions—delivering high-quality reports at scale.
• Elimination of Bottlenecks: AI-driven workflows streamline updates, reduce back-and-forth between teams, and minimize manual rework throughout the regulatory writing process.

Key Use Cases and Document Types

• Clinical Study Reports (CSRs)
• Patient narratives
• Quality Overall Summaries (QOS) for CMC submissions
• Regulatory submissions aligned with ICH M4Q(R2) guidelines
• Broader regulatory and medical writing documentation for health authority submissions

Customer Validation

• Eli Lilly has described Yseop as bringing a novel approach to regulatory submissions and other reporting, with opportunities to extend the technology across the enterprise—from drug discovery to clinical trials, manufacturing, and patient support.
• Lilly's CIO of Medicine Development has noted that each day a new drug or vaccine reaches market sooner creates $1–3 million in accelerated revenue, underscoring the business impact of Yseop's automation.
• Sanofi's domain lead has highlighted that Yseop's AI delivers 100% reliable first drafts that require no further editing by human medical writers, meeting the stringent accuracy requirements of health authority submissions.
• Yseop has a strategic investment and agreement with Eli Lilly & Company, and a long-standing partnership with Sanofi.

Awards and Recognition

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

Company Profile and Values

• Over 90 employees comprising a talented and diverse global team
• More than 10 years of experience redefining what is possible with AI in life sciences
• Global reach, supporting clients across multiple countries
• Relies on an ecosystem of strategic partners to implement Generative AI across top pharmaceutical firms worldwide
• Core values include Trust, Innovation, Teamwork, Agility, and Customer Centricity
• Committed to Corporate Social Responsibility, including sustainability, community engagement, and diversity and inclusion
• Headquartered with expanded sales, marketing, and customer service teams in New York City

Yseop continues to lead the evolution of AI-powered regulatory writing, helping life sciences teams eliminate inefficiencies, enhance compliance, and accelerate the path to market—so that life-changing therapies reach patients faster.