AI for Modern Regulatory Teams
Smarter IND Submissions, Powered by AI
Filyn helps regulatory teams move from document chaos to structured, submission-ready packages — with clarity, speed, and confidence.
Bringing a new therapy to patients takes more than great science — it takes moving fast, staying organized, and meeting complex regulatory demands. But for many early-stage biotechs, preparing an IND is still a slow, manual process. Files are scattered. Work is duplicated. Teams rely heavily on consultants just to meet basic requirements.
This drains valuable time and money, delays key milestones, and puts unnecessary pressure on lean teams. In a space where every month counts, biotech leaders need better tools — not just to manage documents, but to bring order, speed, and clarity to the entire submission process.
Filyn IND Builder
From day one to submission day, Filyn brings clarity, control, and speed to your IND process — without adding headcount or overhead.
Centralized Control, Full Visibility
See everything in one place.
Filyn gives your team a unified workspace to manage active INDs, track deadlines, and assign ownership — no more status meetings or chasing updates.
Built-in Structure, Not Just Storage
Start organized. Stay aligned.
Work inside a pre-built eCTD framework tailored to FDA expectations. Assign leads by module, configure timelines, and eliminate file chaos before it starts.
Smarter Uploads, Less Manual Work
Automation that saves hours.
Filyn’s AI auto-tags and checks every document as it’s uploaded — flagging issues early and reducing time spent on formatting, compliance, and metadata cleanup.
Streamlined Authoring and Collaboration
Write faster, review smarter.
Draft core documents using FDA-aligned templates with built-in guidance. Review and finalize content in one system — with full version history and audit trails.
Real-Time Readiness Tracking
No surprises at submission time.
Track completion across modules with visual dashboards and AI-powered gap alerts. Always know what’s ready, what’s missing, and what needs action.
Fast, Confident Submission
One-click compilation. Built-in validation.
Generate your full eCTD package with just a few steps. Preview, validate, and prepare for ESG upload — with confidence that every file meets spec.
Built for the Realities of Drug Development
Whether you're preparing your first IND or managing submissions across programs, Filyn adapts to the way regulatory work really happens — fast-moving, complex, and resource-constrained.
Start Strong
Filyn helps you build structure from day one — with a guided workspace, auto-tagged content, and FDA-aligned templates to keep everything on track.
Move Fast, Stay in Control
When deadlines are critical, Filyn reduces delays through automation, built-in collaboration, and real-time readiness tracking.
Bring Order to Complexity
Handle multi-module, cross-functional submissions with ease. Filyn maps every document to its place and keeps owners accountable.
Operate Lean
Replace fragmented tools and manual effort with a smarter, more scalable system — lowering prep costs without compromising quality.
Collaborate Without Chaos
Regulatory, clinical, CMC — all aligned in one platform. Track status, exchange feedback, and finalize content in less time.
Scale with Confidence
Whether you’re managing one IND or expanding globally, Filyn keeps your process consistent, traceable, and audit-ready.
Ready to Simplify Your IND Process?
Let’s talk about how Filyn can help your team move faster, reduce overhead, and stay in control — from day one to submission.