Peer AI Secures $12.1 Million in Funding to Innovate Drug Approval Processes

Peer AI Secures $12.1 Million in Funding for Innovative Drug Approval

Peer AI, an advanced platform leveraging agentic AI for regulatory documentation in the life sciences sector, has announced a significant funding round of $12.1 million. The investment, led by Flare Capital Partners with participation from SignalFire and several other notable investors, aims to accelerate drug approval processes by overcoming widespread challenges in regulatory documentation.

In the realm of drug development, generating documents for regulatory approval remains a crucial bottleneck. Traditional methods often require the compilation of over 200,000 pages across more than 1,500 distinct documents. The manual and fragmented nature of these tasks frequently results in incomplete data and inconsistencies, which can hinder the approval processes. Statistics reveal that nearly a third of submissions to the FDA encounter quality issues, and as many as 75% of applications face rejection, causing unacceptable delays.

Peer AI's solution uniquely integrates purpose-built AI agents with a user-friendly interface that allows medical writers to intervene at key control points throughout the documentation process. This innovative approach has already proven invaluable for top 20 pharmaceutical companies and emerging biotechnology firms, helping them save thousands of hours and enhance the quality of their regulatory submissions.

Notably, clients using Peer AI report remarkable reductions in drafting times. For instance, clinical study report (CSR) preparation has been cut down from 40 working days to just 17, and the turnaround for protocols has shrunk from 6-8 weeks to only one week. Some users have experienced a staggering 55-94% acceleration in their documentation processes. Daily active engagement with the platform has tripled in the first three quarters of 2025, while the overall volume of usage has surged by six times, indicating strong market adoption.

Anita Modi, CEO and co-founder of Peer AI, emphasized the company’s mission: “Our vision is to create an intelligent regulatory workflow that interconnects documentation, data, and decision-making to expedite drug approvals.” Modi added that efficient documentation is foundational to all aspects of drug development, which is why they are empowering medical writers with agentic AI tools. This enables faster document generation, improved quality, and ultimately helps deliver treatments to patients more swiftly.

Peer AI's agentic AI technology tackles the core challenges of regulatory documentation with a fusion of automation and human oversight. Specific agents assist with multi-dimensional document creation, facilitating the drafting of various essential documents, including protocols, CSRs, IND applications, investigator's brochures, and more. With data source agents efficiently extracting relevant information and ensuring seamless database integration, and authoring agents drafting compliant documents, the peer-led deployment model guarantees that users receive expert-led support during onboarding and training.

The funding announced is viewed as a pivotal investment in a burgeoning market estimated at $15 billion, with Peer AI poised to expand both product development and market reach in response to increasing demands. Established by veterans of the AI and life sciences industries, the platform seeks to streamline processes while assuring accuracy across vast networks of interconnected documents.

Investors, including Ian Chiang from Flare Capital Partners, noted the potential of GenAI-based tools to unlock significant value in drug discovery and clinical development. “Peer AI’s focused approach to regulatory documentation, driven by in-house medical writing expertise, is already showing promising client engagement and positions the company to become a leading platform in this domain,” Chiang expressed. Furthermore, Sooah Cho from SignalFire recognized the firm's unique capabilities in reshaping an traditionally fragmented workflow into a cohesive and efficient operation.

Among the advisory board are prominent figures such as Ariel Katz, CEO of H1, Brian Longo, a veteran in the life sciences sector, and Hanlin Tang, co-founder at MosaicML.

Peer AI's agentic platform is already available, and interested parties can learn more about it through various upcoming industry events, including the RAPS Convergence and AMWA Medical Writing Communications Conference. With active engagement across the life sciences sector, Peer AI is set to transform the regulatory documentation landscape, accelerating timelines and enhancing the overall quality of submissions for pharmaceutical, biotech, and Contract Research Organizations (CRO) worldwide.

For more information about Peer AI and their cutting-edge solutions, visit getpeer.ai.

About Peer AI

Peer AI is revolutionizing regulatory documentation within life sciences through specialized AI agents that significantly reduce documentation drafting times. The platform enhances document creation across various regulatory submissions while ensuring medical professionals retain oversight. The company is backed by leading investors and driven by a team of experts in AI and life sciences.

About Flare Capital Partners

Flare Capital Partners specializes in healthcare technology investments, aiming to foster innovation that enhances health outcomes and optimizes healthcare access while minimizing costs.

About SignalFire

SignalFire utilizes a data-driven approach to support founders in building and scaling their startups across multiple sectors, including Health and PharmaTech.