Built with biopharma, for biopharma.
Get your IND submission ready in weeks, not months.
Filyn delivers a secure, purpose-built, AI-native workspace that streamlines IND preparation — reducing timelines, minimizing rework, and getting therapies to patients faster.
Friction in IND Preparation
- Siloed authoring across functional teams and systems
- Version churn with overlapping reviews and conflicting edits
- Content gaps or inconsistencies identified late in the process
- Manual effort required to package and secure sign-offs for submission
Our Early Focus
- Consistency across teams — aligning content and reducing silos
- Control over versions — keeping reviews structured and traceable
- Readiness confidence — identifying issues before they create delays
- Submission alignment — outputs structured to meet regulatory standards
Filyn starts with IND — the pivotal gateway to first-in-human trials. From this starting point, our technology is designed to grow into NDA, BLA, and global filings — building toward the future of AI-native regulatory infrastructure.
Early Access Capabilities
AI Drafting Assistant
Generates structured baseline content, providing authors with a consistent starting point and enabling experts to focus on review and scientific judgment.
Completeness Check
Performs automated checks across documents to flag missing sections or inconsistencies earlier in the process, helping reduce late rework.
Collaboration Hub
A secure, eCTD-aligned workspace where teams manage versions, comments, and sign-offs in one place, maintaining traceability and control.
These capabilities are offered in early access for evaluation within defined IND sections. All outputs require expert review and validation. We are inviting partners to join us in shaping the platform as it evolves.
Why Participate Now
Explore Ways to Ease Submission Workload
Early access lets you see how AI-assisted drafting might reduce repetitive authoring and reconciliation, while keeping expert judgment central.
Evaluate Tools for Earlier Issue Detection
Pilot automated checks designed to surface missing contents sooner, with all findings subject to your review and validation.
Prepare for Evolving Regulator Expectations
Gain familiarity with AI-supported approaches that regulators are beginning to explore, in a controlled, evaluation-only setting.
Our Approach and Edge
Practical and credible for today’s INDs. Scalable and defensible as tomorrow’s regulatory infrastructure.
Shaped by Regulatory Reality
Co-developed with regulatory teams and former FDA reviewers, so every feature maps to real submission workflows.
Compliance by Design
Built around eCTD standards with permissions, version locks, sign-offs, and validation engineered for credibility and adoption.
AI with Guardrails
Specialized AI agents draft, check, and organize — always under human oversight, with audit trails and full explainability.
Compounding Advantages
Each expert edits enrich a proprietary regulatory corpus, creating a defensible data moat that grows with every filing.