Coming Soon
Early Access Program
A collaborative pilot for biotech, CRO/CDMO, and regulatory consulting teams who support IND submissions — offering a safe, structured way to explore AI-assisted drafting and improve clarity and consistency across key sections, without altering your current workflows.
How the Early Access Program Works
A short, guided evaluation that runs alongside your existing work — with minimal time and no workflow changes.
The Early Access Program gives your team a safe, controlled way to experience Filyn using real or historical content. It requires only a small group, no preparation, and no changes to your current tools or processes. The purpose is straightforward: let your regulatory and writing teams see how AI-assisted drafting, quality and completeness checks, and collaborative review workflows can support clearer, more consistent, and more traceable content — without adding burden or risk. Program participation is free of charge.
1. Quick Kickoff & Shared Goals
A brief discussion with your designated point of contact to understand how your team currently develops and reviews content, and to align on what you want to evaluate — such as drafting efficiency, consistency, clarity, reviewer experience, or quality checks. Success criteria are simple and mutually defined.
2. Private Workspace Setup (Under NDA)
We set up your secure workspace, tailor templates to match your expectations and style, and load the content you choose to use. No IT involvement, no integrations, no onboarding, and no changes to your existing systems or processes.
3. Guided, Hands-On Session
Your team (typically 2–3 people) joins a live, structured session where we walk through drafting, quality/completeness checks, and collaboration workflows together. No preparation is required. Participants can engage directly or simply observe — whichever is most comfortable. All AI-assisted suggestions remain fully transparent, editable, reviewable, and traceable.
4. Review, Compare, and Choose Next Steps
You compare what you experienced with your usual process. From there, you can conclude with a clear assessment or — if useful — continue with additional evaluation. You may also choose to become a Design Partner, which includes ongoing free access during the partnership and the ability to help shape future development.
✓ Completely free of charge
✓ Minimal time commitment (one guided session)
✓ Uses real or historical content — no impact on active submissions
✓ Runs alongside your current workflow and tools
✓ Fully governed, NDA-protected environment
✓ Optional Design Partner path (continued free access and roadmap influence)
What We’ll Explore Together
✔ How a Structured Workspace Supports Clearer, More Aligned Content
See how working within a consistent structure can help authors and reviewers move toward clearer, more coherent content — without changing your current tools or processes.
✔ How Teams Maintain Alignment Across Authors, SMEs, and Reviewers
Explore how a shared environment, with unified access to content and comments, can help contributors stay aligned throughout drafting and review.
✔ How Governed, Transparent AI Can Assist Regulatory Writing
Experience AI-assisted drafting and quality/completeness checks in a controlled, fully reviewable environment where your team remains in full control of every decision.
✔ How Filyn’s Approach May Support Future Submission Needs
Get exposure to upcoming capabilities and, if you choose, provide input through an optional design-partner collaboration that helps inform future development.
All features and capabilities are provided for evaluation purposes only and may change prior to general availability. Filyn does not provide regulatory, legal, or clinical advice. Any AI-generated content is draft material intended to assist qualified experts and must be reviewed and validated prior to inclusion in regulatory submissions. Filyn is provided ‘as is’ without warranties of any kind, and we disclaim liability for any errors, omissions, or outcomes arising from reliance on the platform or its outputs.