Peer AI, a platform specializing in agentic AI for regulatory documentation in the life sciences, has successfully raised $12.1 million in funding. This investment round was led by Flare Capital Partners and SignalFire, with additional support from notable investors such as Greycroft, Atria, Alumni Ventures, Gaingels, and Mana Ventures. Several strategic angel investors from the life sciences, healthcare, and technology sectors have joined this funding round, underscoring the growing interest in innovative solutions for regulatory challenges.
Generating regulatory documents for new drugs presents a daunting obstacle in the drug development process. Typically, a single new drug requires the creation of over 200,000 pages, encompassing more than 1,500 unique documents. The traditional methods of document preparation are manual and often fragmented, which can lead to missing data and discrepancies.
This inefficiency has significant consequences; nearly one-third of FDA submissions face quality issues, and regulators reject about 75% of applications. Such rejections can delay approvals by an average of 435 days, hindering the timely delivery of new treatments to patients.
The Peer AI platform stands out by leveraging purpose-built, domain-specific AI agents complemented by a user-friendly AI-powered interface. This unique combination enables medical writers to utilize their subject matter expertise effectively at key points in the documentation workflow.
Clients, including top pharmaceutical companies and emerging biotech firms, are reportedly saving thousands of hours while enhancing the quality of their regulatory documents across various domains, such as preclinical, clinical, regulatory affairs, and chemistry, manufacturing, and controls (CMC).
The benefits of using Peer AI are significant. Customers have reported acceleration in drafting times ranging from 55% to an impressive 94%. In addition to saving time, organizations have experienced reductions in costs, improved consistency, and increased accuracy in their documentation—all while ensuring compliance with regulatory standards.
For example, medical writing teams have managed to cut the drafting time for clinical study reports (CSRs) from 40 days to just 17 days, and they have streamlined protocol turnaround times from 6-8 weeks to merely one week. The platform has seen a threefold increase in daily active usage during the first three quarters of 2025, and overall platform activity has surged sixfold, indicating a robust market adoption.
Peer AI effectively addresses the challenges associated with regulatory documentation by merging agentic AI automation with strategic and easy-to-use human control points. This combination ensures efficiency while maintaining high standards of integrity throughout the documentation process.
The platform features purpose-built medical writing agents that assist experts in creating multi-step documents. These agents can generate essential documents such as protocols, CSRs, investigational new drug (IND) applications, investigator’s brochures (IBs), and plain language summaries. Additionally, data source agents extract information from complex sources and ensure seamless integration with databases. Authoring agents craft accurate drafts that adhere to regulatory guidelines, style agents uphold compliant formatting, and post-processing agents conduct final validation checks.
The platform offers an intuitive user experience, allowing experts to verify, validate, and maintain quality control of content throughout the documentation workflow. This peer-led deployment model is bolstered by a dedicated team of medical writers who facilitate training, onboarding, and change management, ensuring that customers achieve a swift return on their investment.
The recent funding not only signals a substantial investment in the life sciences sector but also comes at a critical time for advancements in regulatory documentation, a market estimated to be worth $15 billion.
This funding will propel Peer AI’s product development and support commercial growth as the company scales to meet rising market demand. Founded by industry veterans with extensive experience in AI and life sciences, Peer AI is uniquely positioned to enhance timelines while ensuring accuracy and consistency across thousands of interconnected pages and documents.
Peer AI has also gained valuable input from notable advisors, including Ariel Katz, CEO and co-founder of H1; Brian Longo, a veteran life sciences advisor and former executive at Veeva Systems; and Hanlin Tang, co-founder of MosaicML and currently the CTO for Neural Networks at Databricks.
The Peer AI agentic platform is now available for use. For those interested in learning more, the Peer AI team will be present at several upcoming events, including RAPS Convergence, AMWA Medical Writing & Communications Conference, Clinical Trial Innovation Summit, SyncUP Summit, and CNS Summit, where attendees can gain further insights and view demonstrations of the solution.
KEY QUOTES:
“Our vision is to create an intelligent regulatory workflow that connects documentation, data, and decision-making to speed drug approvals. Documentation drives every step of the drug development process. We’re putting agentic AI in the hands of expert medical writers to create documents faster, improve quality, and, ultimately, accelerate treatments to patients.”
Anita Modi, CEO and co-founder of Peer AI
“We see enormous opportunity in GenAI-based tools to unlock value in drug discovery and clinical development processes, including automating the end-to-end process of regulatory documentation. Peer AI’s distinctive approach and specialized agentic AI platform are shaped by in-house medical writer expertise. They’re already demonstrating strong early client engagement and poised to become a category-defining platform.”
Ian Chiang, partner at Flare Capital Partners
“The Peer AI team’s deep expertise across life sciences and AI uniquely positions them to drive greater efficiency in the entire drug development workflow. They’re establishing the foundational regulatory backbone for life sciences to transform a historically fragmented, manual process with a unified agentic platform and intuitive user experience that brings experts in the loop at the right times.”
Sooah Cho, partner at SignalFire
