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 guided, low-burden evaluation that runs in parallel with your existing work — with minimal time investment and no changes to your current tools or processes.
The Early Access Program gives your team a controlled, NDA-protected environment to explore Filyn using real or historical content. Only a small group is needed, and no preparation is required. The goal is simple: help your regulatory teams see how AI-assisted drafting, quality and consistency checks, and structured collaboration can support clearer, more aligned, and more traceable IND-related content — without risk or disruption. Program participation is free of charge.
1. Quick Kickoff & Shared Goals
A short conversation with your designated point of contact helps us understand your current drafting and review approach and align on what you want to evaluate — such as clarity, consistency, scientific QC support, reviewer experience, or drafting efficiency. Success criteria are kept straightforward and mutually defined.
2. Private Workspace Setup (Under NDA)
We create your isolated workspace, apply templates that match your expectations, and load the content you choose to explore. No IT involvement, no integrations, no onboarding steps, and no changes to existing systems or validated processes.
3. Guided, Hands-On Session
Your team (typically 2–3 participants) joins a live, structured session where we walk through drafting assistance, quality/completeness checks, and review workflows together. No preparation is required. Participants may engage directly or observe — both are fully supported. All AI-assisted outputs are transparent, editable, reviewable, and traceable at every step.
4. Review, Compare, and Determine Next Steps
Your team compares what you experienced with your usual approach and forms a clear, evidence-based assessment. You may conclude the evaluation at this point or continue with additional exploration if helpful. Some teams are invited to join as Design Partners, which includes extended free access during the partnership and the opportunity to help shape Filyn’s development. Participation is optional.
✓ Free of charge
✓ Minimal time commitment (one guided session)
✓ Uses real or historical content — no impact on active submissions
✓ Runs entirely alongside existing workflows and tools
✓ Fully governed, NDA-protected environment
✓ Optional Design Partner path with continued access and influence
What We’ll Explore Together
How Governed, Transparent AI Can Safely Support Regulatory Writing
See AI-assisted drafting in a controlled, fully reviewable environment where your team remains in full control — gaining clarity on how AI can responsibly fit within your workflow.
How AI-assisted Quality Checks Fit Into Your Review Flow
Explore how built-in checks can help surface missing or inconsistent elements earlier in drafting, supporting a smoother review process without adding extra steps.
How a Structured Workspace Supports Well-Organized Content
See how working within an organized, consistent workspace helps authors produce clearer, more cohesive sections — without changing your current tools or processes.
How Teams Stay Aligned Across Authors, SMEs, and Reviewers
Experience how authors, SMEs, and reviewers stay better connected via shared access to content, comments, source materials, reducing misalignment across versions and handoffs.
Who This Program Is Designed For
Biopharma teams engaged in IND programs
Regulatory writers, regulatory leads, and functional SMEs working across multiple sections who want stronger structure, traceability, and coordination in how content is drafted and reviewed.
Biotech teams with lean regulatory capacity
Smaller biotech teams that want more support for drafting and coordination in-house, to make better use of external consultants and CROs — without adding new tools or process overhead.
CRO & CDMO teams supporting sponsor submissions
Teams drafting or reviewing content for sponsors who want clearer organization and more predictable coordination across contributors and client reviewers.
Regulatory consulting teams working across sponsors
Consultants handling varied templates, expectations, and source materials who need an organized way to manage inputs and revisions across projects.
Governance & Data Protections
The program takes place in a contained, NDA-protected environment designed to maintain confidentiality, respect organizational boundaries, and ensure your team retains complete oversight of how content is used. The program requires no integrations, no installations, and no changes to your internal systems or workflows.
✔ NDA-Protected, Isolated Workspace
Each organization receives a private workspace under NDA. Access is limited to individuals you designate. Workspaces are isolated from one another, and no data is shared between organizations.
✔ No Integrations, Installations, or System Access Required
The evaluation runs entirely in a secure, browser-based environment. It does not require installing software, connecting to internal networks, integrating with your DMS, or providing system credentials. Your IT infrastructure and validated processes remain unchanged.
✔ Your Content Remains Under Your Organization’s Control
You choose what to upload, who can access it, and how long it remains available. Content can be removed at any time. Nothing is written back into your internal systems, and no materials are accessed without your explicit action.
✔ No Training or Fine-Tuning of General Models on Customer Content
Content used during the evaluation is not used to train, adapt, or improve general models. It is processed only to support activity within your isolated workspace and is not retained for model development.
✔ Transparent, Reviewable AI Assistance
All AI-assisted suggestions are displayed in a fully reviewable, editable format. Nothing is applied automatically, and all material remains subject to your authors’ and reviewers’ judgment and approval.
✔ Human Oversight and Retention of Final Responsibility
Filyn supports drafting and QC workflows but does not replace regulatory judgment. Your team remains responsible for all decisions, authorship, and final content.
✔ No Dependencies Introduced Into Active Submissions
The evaluation uses real or historical content in an isolated workspace. Because it does not modify your internal processes or systems, it has no impact on ongoing submissions, validated environments, or production workflows.
Frequently Asked Questions
What is the purpose of this Early Access Program?
The program is designed to give your team a contained, low-effort way to evaluate whether Filyn’s structured workspace and AI-assisted support could have a place in your regulatory writing and review process. It is an opportunity to observe, not a commitment to adopt.
What will my team actually get out of participating?
Teams use the evaluation to see, in a concrete way, how a structured workspace, quality/completeness checks, and governed AI assistance behave on their type of content. The goal is to help you form an informed view of “where, if anywhere, this fits for us” based on real examples rather than slideware.
How much time and how many people are required?
The evaluation is intentionally light. Most organizations involve a small group (typically 2–3 people) and one point of contact. The main activity is a single guided session; preparation on your side is minimal.
Will this change our existing workflow, tools, or templates?
No. The evaluation runs in a separate, browser-based workspace and does not alter your tools, templates, publishing systems, or processes. It is designed to sit alongside your current way of working, not replace it.
Does this touch active submissions or validated environments?
No. The program is kept separate from active submissions and validated systems. You decide which real or historical materials to use, and nothing is written back into your internal systems.
Do we need IT, QA, or Legal involved?
That depends on your internal policies, but the program is structured to make those conversations straightforward:
- No installations or integrations,
- No access to internal systems,
- NDA-protected, isolated workspace,
- No use of your content to train general models.
We can provide a concise description of the evaluation for internal review if needed.
How is confidentiality and data use handled?
Each organization has its own NDA-protected, isolated workspace. You control what is uploaded and who can access it. Content is not used to train or fine-tune general models and can be removed at any time.
Who remains responsible for the content and decisions?
Your team. Filyn is intended to assist drafting and checks, not replace regulatory judgment. All AI-assisted suggestions are reviewable and editable, and your authors and reviewers remain responsible for all decisions and final content.
Is there a cost or commercial commitment?
No. The Early Access evaluation is free of charge. Participation does not create an obligation to purchase, continue, or expand use.
What happens after the program?
You can simply conclude with a clear internal assessment and no further action. If you see value and timing is right, you may choose to continue exploring or consider a Design Partner path, which includes extended access and input into future development. This is optional.
Is this only relevant if we are actively preparing an IND right now?
No. The program is appropriate for teams working on IND-related content, planning future submissions, or evaluating how structured, AI-assisted drafting might play a role over time. You decide what examples make sense to use.
What if we are interested but not ready to schedule an evaluation yet?
You can register your interest, and we will notify you as future evaluation windows open. This allows you to align internal timing before committing to a session.
Request Early Access
Early Access will open in limited waves so each participating team can receive a focused, well-supported evaluation.
Filyn’s features, capabilities, and outputs are provided solely for exploratory and evaluation purposes and are not intended for use in active regulatory submissions, validated workflows, or any activities requiring compliance with regulatory, legal, or clinical standards. All functionality is subject to change prior to general availability, and no representation is made regarding future availability, performance, or suitability. Filyn does not provide regulatory, legal, medical, or clinical advice. Any AI-generated text, analysis, or suggestions are draft materials intended only to support qualified professionals and must be independently reviewed, verified, and approved by appropriately trained experts before being used in any regulated context. Users remain fully responsible for the accuracy, scientific integrity, completeness, and compliance of all content they develop or evaluate within Filyn. The platform is provided “as is,” without warranties of any kind—express or implied—including, but not limited to, warranties of accuracy, completeness, reliability, or fitness for a particular purpose. Filyn disclaims all liability for any errors, omissions, interpretations, decisions, or outcomes arising from the use of the platform or reliance on its outputs. Use of Filyn during Early Access does not create any obligation or commitment regarding future access, product direction, or support. Use of the platform is voluntary, and users should ensure that their participation aligns with their organization’s internal policies, quality requirements, security expectations, and regulatory obligations.