Peer AI Raises $12.1 Million to Accelerate Drug Approvals with an Intelligent Regulatory Workflow

Specialized AI agents combined with precise human-in-the-loop control points create accurate, high-quality regulatory documents up to 94% faster

SAN FRANCISCO, Oct. 7, 2025 /PRNewswire/ -- Peer AI, a leading agentic AI platform for life sciences regulatory documentation, today announced $12.1 million in total funding, led by Flare Capital Partners and SignalFire. Other investors included Greycroft, Atria, Alumni Ventures, Gaingels, and Mana Ventures, along with strategic angel investors from across the life sciences, healthcare, and technology industries.

Generating documentation for regulatory approval remains a critical drug development bottleneck. New drugs require over 200,000 pages spanning more than 1,500 unique documents. Manual and fragmented processes lead to missing data and discrepancies, often stalling approvals. Nearly one-third of FDA submissions have quality issues, and regulators reject almost 75% of applications, causing delays of 435 days.

The Peer AI 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. Top 20 pharmas and emerging biotechs are saving thousands of hours and improving quality of regulatory documents across pre-clinical, clinical, regulatory affairs, and chemistry, manufacturing, and controls (CMC) with Peer AI.

Customers are accelerating drafting times by 55–94%, cutting costs, and improving consistency and accuracy, while maintaining regulatory compliance. Medical writing teams have reduced clinical study report (CSR) drafting time from 40 to 17 working days and cut protocol turnaround from 6-8 weeks to just one week. Daily active use has grown 3X in the first three quarters of 2025, while overall platform volume has increased 6X, demonstrating strong adoption.

"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."

Agentic AI addresses regulatory documentation challenges

Peer AI uniquely combines agentic AI automation with strategic, easy to use human control points to scale AI-powered regulatory documentation efficiently and with the highest level of integrity. Purpose-built medical writing agents support experts in multi-step document creation, generating documents such as protocols, 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. Authoring agents create accurate drafts aligned with regulatory guidelines, style agents ensure compliant formatting, and post-processing agents perform final validation checks.

With an intuitive user experience, 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.

Strong market opportunity and validation

Today's news signals a significant investment in an important market – which is estimated to be $15 billion – to make regulatory documentation more efficient. 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, Peer AI is speeding 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."

"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," said Sooah Cho, partner at SignalFire. "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."

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. For more information, meet the Peer AI team at upcoming events, including RAPS Convergence, AMWA Medical Writing & Communications Conference, Clinical Trial Innovation Summit, SyncUP Summit , and CNS Summit to learn more and see a solution demo.

About Peer AI
Peer AI transforms regulatory documentation for life sciences companies through specialized AI agents that reduce drafting time. The agentic AI platform automates document creation across protocols, clinical study reports (CSR), narratives, investigational new drug (IND) applications, investigator's brochures (IBs), and plain language summaries, while medical writers maintain oversight and control. Peer AI serves pharmaceutical, biotech, and CRO organizations worldwide. The company is backed by top investors and led by industry veterans with decades of experience in AI and life sciences. For more information, visit getpeer.ai.

About Flare Capital Partners

Flare Capital Partners is the leading healthcare technology venture capital firm advancing innovation-driven companies to improve positive health outcomes, broaden care access, and lower healthcare costs. We partner with exceptional founders solving healthcare's hardest challenges, supporting each with our deep sector expertise, unparalleled industry resources, and proven access to commercial opportunities. Our team of established investors and senior operating executives has invested in 70+ companies and has nearly $1 billion in assets under management. To learn more about Flare Capital Partners, please visit flarecapital.com or follow us on LinkedIn, YouTube, or Spotify.

About SignalFire

SignalFire is the first AI-native VC firm built like a technology company to better serve the needs of founders as they build and scale their startups. With approximately $3B in assets under management, SignalFire invests in applied AI companies from pre-seed to Series B in key sectors, including Health & PharmaTech, cybersecurity, infrastructure, consumer, and other enterprise verticals.

The firm's Beacon AI platform tracks over 650M employees and 80M organizations, giving the firm an unmatched data advantage in identifying and supporting world-class startups. Its sector-focused investors, XIRs from leading Health & PharmaTech unicorns, and a dedicated team of seasoned operators drive SignalFire at startup speed. They provide support across a company's full lifecycle through data and resources tailored by growth stage, plus a diverse ecosystem of partners and customers. Notable investments include Grow Therapy, Ro, EvenUp, Frame.io, Grammarly, and Stampli.

Learn more at www.signalfire.com.

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SOURCE Peer AI