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<p class="normal">Let’s talk about how Filyn can help your team move faster, reduce overhead, and stay in control — from day one to submission.</p>

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<p>Save time. Slash costs. Reinvent regulatory with us.</p>

Filyn

Filyn is an AI-powered software platform designed to streamline and accelerate the drug regulatory submission process, with a particular focus on INDs (Investigational New Drug applications) — a major bottleneck in clinical development.

📌 Core Business Description
Filyn helps biotech and pharma companies shift from chaotic, manual submission preparation (which typically involves scattered documents, spreadsheets, and email threads) to a centralized, automated, and audit-ready system. This shift cuts submission timelines from months to days, saving companies significant money and reducing the risk of delays that can cost up to $8 million per month.

🧠 Key Features
AI-powered automation for preparing IND submissions
Document control, version tracking, and risk prediction
End-to-end platform with potential expansion to global regulatory filings and intelligence
📈 Business Model
Entry: $25K–30K per IND filing (project-based for IND-stage biotech)
Scale: $75K–250K annual contracts (scaling biotechs, mid-sized pharma)
Expansion: $300K–750K+ enterprise licenses (CROs and large pharma)
Value proposition: Saves $100K+ per filing and accelerates approval timelines
🏁 Go-to-Market Strategy
Start with urgent IND buyers via VC/consultant referrals and time-sensitive pilots
Expand by embedding into teams adjacent to regulatory (clinical, quality, etc.)
Grow into multi-year SaaS deals with high NRR and LTV
🌍 Market Opportunity
TAM: $3–5B (global regulatory tech & services)
Wedge: 600–800 IND filings/year in the U.S. at $25K–30K each
Long-term goal: become the global command center for regulatory strategy
👥 Team
Led by Xin Yang, PhD MBA
Supported by strategic advisors with expertise in biotech, pharma, regulatory, AI, and venture capital