From IND to Infrastructure
Filyn begins with IND — the pivotal milestone before first-in-human trials. IND is our starting point, but not our destination. From this foundation, the platform is designed to expand into NDA, BLA, and global submissions — ultimately advancing toward an AI-native regulatory and compliance OS for biopharma.
Building on the Right Foundation
IND recurs throughout development and requires the same cross-functional coordination as larger submissions, while consuming scarce time and resources.
This makes IND the most practical and credible proving ground for AI-native workflows — where solving this milestone delivers immediate value and establishes a foundation that can naturally extend to later filings and, over time, broader compliance.
A Market Ready for Change
Three forces are converging to make transformation inevitable
AI Readiness
Advances in AI now make it possible to generate, review, and structure complex documents with reliability and traceability — capabilities that were out of reach only a few years ago.
Regulatory Signals
FDA and global regulators are piloting AI in their review processes, signaling growing readiness to integrate digital approaches into the oversight of drug development.
Market Urgency
Biopharma teams are leaner, development costs are rising, and timelines remain critical. The pressure to accelerate submissions while maintaining compliance has never been greater.
These forces are converging to create a $25B+ opportunity to modernize regulatory submissions and compliance. By starting with IND, Filyn delivers measurable value where the impact is most immediate, while building the foundation to scale across the lifecycle.
Built to Compound
Filyn strengthens with every filing — combining human expertise, specialized AI agents, and a growing regulatory corpus into a system that compounds accuracy, trust, and defensibility over time.
Collaborative AI Agent System
Specialized AI agents for drafting, auditing, and orchestration work alongside domain experts to deliver reliable, explainable outputs — a scalable foundation that goes beyond ad-hoc model use.
Human Validated Learning Loop
Every expert edit and approval feeds back into the system, creating a structured cycle of reinforcement that continually strengthens accuracy, reliability, and trust.
Regulatory Data Network Effect
Each filing interaction contributes to a proprietary, domain-specific corpus that grows over time — compounding into a defensible data asset that generic AI cannot replicate.
From Copilot to Orchestrator
Filyn’s AI is designed to grow in capability as the platform scales across submissions — progressing from accelerating individual tasks to orchestrating the full regulatory process.
AI Copilot
Drafts modules in minutes instead of months, freeing experts from repetitive writing so they can focus on higher-value work.
AI Auditor
Reviews content with a critical eye, flagging gaps, inconsistencies, and risks early — preventing costly rework and regulatory delays.
AI Strategist
Learns from past filings to anticipate regulator questions, highlight potential objections, and guide teams toward stronger submission strategies.
AI Orchestrator
Coordinates across teams, documents, and systems — managing submissions and compliance end-to-end with traceability, efficiency, and scale.
Shaping the Future Infrastructure
Filyn’s path is deliberate: start with IND, scale across filings, and evolve AI from copilot to orchestrator. The destination is more than faster submissions — it is an AI-native infrastructure that connects regulatory and compliance into one trusted, compounding system. A foundation designed not just to support the next filing, but to redefine how biopharma advances new therapies worldwide.