Oct 7, 2025

From the Desk of the CEO: Accelerating Drug Development Through an Intelligent Regulatory Workflow

From the Desk of the CEO: Accelerating Drug Development Through an Intelligent Regulatory Workflow

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Today, I’m excited to announce that Peer AI has raised $12.1 million in funding. This milestone matters because of what it enables us to do: impact how drugs get to patients who need them.

Before starting Peer AI, I spent over a decade building technology for clinical trials at companies like Science 37 and Genos. As Chief Quality Officer at Science 37, I saw firsthand how the drug development process remained shockingly manual and error-prone.

A major culprit? Documentation.

Unless you work in drug development, you probably don’t realize that documentation is the backbone of the entire process. Every drug that reaches patients requires over 1,500 unique documents spanning more than 200,000 pages. These aren’t simple forms—they’re highly technical documents written by PhDs and MDs, each requiring hundreds of hours to create. Regulatory decisions depend on them. They gate every step from molecule to market.

And today, much of this work remains highly cumbersome.

While servicing clinical trials, I watched quality issues emerge not because people lacked intelligence, competence, or care, but because they were clicking through multiple systems, doing manual data entry, and sending files by email. The workflows were fragmented, built for a pre-digital (and certainly pre-AI) era. When my co-founders Ravi, Chris, and I saw what agentic AI could do, we knew it would fundamentally change how subject matter experts do this work.

Not replace them—support them. Be a peer to them.

Why Now is Different

We’re living through one of the most significant technology transformations since the internet, and it’s happening at break neck speed. The leap from GPT-3 to GPT-4 to agentic AI systems represents a fundamental shift in what’s possible. 

To the industry’s credit, life sciences is embracing this shift with urgency. Coupled with that, the FDA is providing thoughtful guidance and encouraging AI adoption. Companies are actively evaluating how to bring AI into their workflows, moving from “should we?” to “how do we do this right?”

The economics of drug development demand this radical change. With patent cliffs approaching for blockbuster medicines and the Inflation Reduction Act reshaping incentives, pharma companies cannot afford to lose years to documentation.

This creates a critical decision point: do organizations work with pre-AI vendors trying to bolt on new capabilities, or partner with AI-native companies building from the ground up?

The difference matters. Bolt on solutions often shift burden rather than eliminate it, forcing teams to reconfigure data pipelines, create new manual steps, or deliver quality so inconsistent it generates more work than it saves. We believe the future needs to be agentic AI native.

How We Aim to Be Different

At Peer AI, we’ve built an agentic AI platform that combines purpose built medical writing agents with precise human control points. Think of it as giving medical writing teams an entire agentic team to help them drive the regulatory documentation process.

We have document-specific agents: a CSR agent that understands what makes a good clinical study report, a protocol agent that both authors and handles amendments, a safety narrative agent, and so on. We also deploy agents that handle different aspects of document creation— one ingests data, another creates templates, and another authors prose, figures, and tables. A dedicated agent focuses on quality control. Data synthesis agents can process thousands of pages of source documents in minutes to seconds. 

But here’s what’s critical: we enable expert teams to inject themselves at strategic points throughout the workflow to check, verify, and validate AI’s work. This combination of automation and human oversight isn’t a compromise. It’s how you scale AI-powered documentation with the level of integrity this industry demands.

The results speak for themselves. Medical writing teams see time savings from 55% to 94% while improving document quality. They've reduced clinical study report drafting from 40 to 17 working days. Protocol turnaround has dropped from 6-8 weeks to one week. Daily active use has grown 3X in the first three quarters of 2025. Platform volume has increased 6X. Top 20 pharmas and emerging biotechs are already working actively on the Peer AI platform. 

Why the Team Matters

Building in this space requires more than great technology. We’re operating on an entirely new frontier of how this work will get done. Getting it right demands deep expertise across multiple domains.

Our founding team brings together decades of experience in bringing drugs to market, cybersecurity, life sciences technology, and the early transformer architecture that led to the LLM revolution. We’ve also built a team of medical writers in-house who lead our training, onboarding, and customer engagement in a peer-to-peer capacity.

The deployment model is just as important as the technology itself. In this era of AI transformation, change management is critical. Our customers aren’t just buying software, they’re partnering with people who understand their workflows, speak their language, and can guide them through this transition. Making existing processes 10X better requires reimagining workflows, not just automating individual steps.

What This Means for the Future

We founded the company to apply AI across complex and time consuming processes, helping get new treatments to patients faster and creating meaningful impact on health outcomes around the globe. We named the company Peer AI because we envision AI working alongside and supporting experts in these processes.

Our philosophy centers on combining AI automation with strategic human control points throughout important drug development workflows. This approach creates something smarter, faster, and more effective than either humans or AI could achieve alone.

Documentation and building an intelligent regulatory workflow is a critical starting point. Capturing data and insights from the documentation process brings greater intelligence to workflows by connecting documentation, data, and decision-making. As we expand this model across drug development, we’ll approach it with the same philosophy: be a peer to experts, apply AI thoughtfully, and maintain human control where it matters most.

We believe Peer AI will become the agentic backbone for the next era of drug approvals. We're transforming how our customers bring cutting-edge science to healthcare markets, workflow by workflow, always with the same goal of getting treatments to patients faster.

The Real Stakes for the Industry

Here’s what sometimes gets lost in conversations about efficiency and automation: time isn’t trivial when you’re talking about medicines that save lives or dramatically improve quality of life.

Every day we save in documentation brings treatments closer to patients who need them. Nearly one-third of FDA submissions have quality issues, and regulators reject almost 75% of applications. These delays average 435 days. These just aren’t just statistics—they represent real people waiting for treatments that could change their health outcomes.

This is why we’re building Peer AI. This is why this funding matters. This is why we believe agentic AI, thoughtfully applied with the right human oversight, will transform not just our industry but human health outcomes worldwide.

The future of drug development will be faster, smarter, and more efficient. Peer AI is building the backbone to make that future real, and we take great pride in helping lead our industry forward. We encourage you to join us, partner with us, follow us, and watch us closely for what comes next from our company.

Anita Modi

Co-founder and CEO

To learn more about Peer AI and see how we're transforming regulatory documentation, visit getpeer.ai or meet our team at upcoming events including RAPS Convergence, AMWA Medical Writing & Communications Conference, Clinical Trial Innovation Summit, SyncUP Summit, and CNS Summit.

Ready to accelerate document creation?

See why biotechs and pharmas trust Peer AI to deliver high-quality, inspection-ready documents.

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Ready to accelerate document creation?

See why biotechs and pharmas trust Peer AI to deliver high-quality, inspection-ready documents.

Cta Image

Ready to accelerate document creation?

See why biotechs and pharmas trust Peer AI to deliver high-quality, inspection-ready documents.

Cta Image