Peer AI, a San Francisco-based startup specializing in agentic AI for life sciences regulatory documentation, announced $12.1 million in total funding to address critical bottlenecks in drug development. The round was led by Flare Capital Partners and SignalFire, with participation from Greycroft, Atria, Alumni Ventures, Gaingels, and Mana Ventures, along with strategic angel investors from across the life sciences, healthcare, and technology industries.
The funding comes as regulatory documentation continues to pose significant challenges for pharmaceutical companies. New drugs require over 200,000 pages spanning more than 1,500 unique documents, with manual and fragmented processes leading to missing data and discrepancies that often stall approvals. According to the company, nearly one-third of FDA submissions have quality issues, and regulators reject almost 75% of applications, causing delays of 435 days.
Agentic AI Platform Delivers Dramatic Efficiency Gains
Peer AI's platform deploys purpose-built, domain-specific AI agents combined with an intuitive AI-powered user interface that allows medical writers to apply their subject matter expertise at critical control points during documentation workflows. The system includes specialized agents for different functions: medical writing agents support multi-step document creation for protocols, clinical study reports (CSRs), investigational new drug (IND) applications, investigator's brochures (IBs), and plain language summaries. Data source agents extract information from complex sources and ensure database integration, while authoring agents create accurate drafts aligned with regulatory guidelines.
Top 20 pharmaceutical companies and emerging biotechnology firms using the platform are saving thousands of hours and improving quality of regulatory documents across pre-clinical, clinical, regulatory affairs, and chemistry, manufacturing, and controls (CMC) functions. Customers are accelerating drafting times by 55-94%, cutting costs, and improving consistency and accuracy while maintaining regulatory compliance.
The results have been particularly striking for specific document types. Medical writing teams have reduced clinical study report drafting time from 40 to 17 working days and cut protocol turnaround from 6-8 weeks to just one week. The platform's adoption metrics reflect strong market validation, with daily active use growing 3X in the first three quarters of 2025, while overall platform volume has increased 6X.
Strategic Human-in-the-Loop Design
"Our vision is to create an intelligent regulatory workflow that connects documentation, data, and decision-making to speed drug approvals," said Anita Modi, CEO and co-founder of Peer AI. "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."
The platform uniquely combines agentic AI automation with strategic, easy-to-use human control points to scale AI-powered regulatory documentation efficiently and with high integrity. Style agents ensure compliant formatting, and post-processing agents perform final validation checks, while experts can verify, validate, and quality control content throughout documentation workflows.
A peer-led deployment model provides an expert team of medical writers to lead training, onboarding, and change management to help customers achieve the quickest time to value.
Significant Market Opportunity
The investment targets a regulatory documentation market estimated at $15 billion. The funding will accelerate product development and commercial expansion as Peer AI scales to meet growing market demand. Founded by industry veterans with decades of experience in AI and life sciences, the company is positioning itself to speed timelines while ensuring accuracy and consistency across thousands of interconnected pages and documents.
"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," said Ian Chiang, partner at Flare Capital Partners. "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."
Sooah Cho, partner at SignalFire, added: "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."
Industry Leadership and Expansion Plans
Peer AI has attracted leading advisors, including Ariel Katz, CEO and co-founder of H1, a data, analytics, and AI platform connecting the world to the right doctors, Brian Longo, 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 available today, with the company planning to showcase its solutions at upcoming industry events, including RAPS Convergence, AMWA Medical Writing & Communications Conference, Clinical Trial Innovation Summit, SyncUP Summit, and CNS Summit.
