The AI Workspace
Built for Regulated Science.
FDA-grade drafts. Zero hallucinations. Every claim traced to your own reference library, not the open internet.
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leaders at
Your team is working on
Million $$$ documents in Word.
The average Phase III CSR takes 6–12 weeks of medical writing time. It lives in shared folders, email chains, and a reference library no one can fully search. When the draft goes to QA, the audit trail is a timestamp on a file name.
That's not a workflow. That's a liability.
AI that knows what an FDA reviewer expects to read.
ProWriter isn't a general-purpose AI writing assistant with a regulatory skin on top. It's a purpose-built workspace where every template, every model, and every citation rule was designed for ICH E3 and FDA submissions from day one.
Grounded. Not guessing.
Every sentence ProWriter generates is sourced from documents you upload, your study reports, amendments, SAPs, and reference literature. If a claim has no source in your library, ProWriter won't write it. No hallucinations. No invented citations. No surprises in QA.
Compliant by architecture, not by policy.
HIPAA-grade infrastructure. End-to-End Encrypted. 21 CFR Part 11 audit trail built into every document and notebook entry. Your IT and compliance team won't need to build a risk framework around ProWriter, we already built it for them.
Faster than any other tool your team has tried.
Industry pilots show AI-assisted regulatory writing cuts CSR drafting time by up to 40–87%. ProWriter customers report saving a median of 87% of time per section, with a draft that doesn't need to be rebuilt from scratch.
From the bench, the clinic, and the desk.
ProWriter is an amazing tool and has helped me a lot. I really love the journal club template.
ProWriter is far better than the many AI tools I have tried. The journal article template is helping me save so much time.
ProWriter will help save my team a ton of time. We are very enthusiastic for the team features!
My experience with AI tools has been hit or miss. ProWriter has definitely been a hit. I love how easy it is to use and how grounded the answers are. I was skeptical at first, but when I tried it out, I was convinced that this was going to be my go-to AI tool on my next project. I honestly wish this tool was around a year ago when I was writing CMC.
I've tried out many AI tools for regulatory writing and highly recommend ProWriter, especially for CSPs, CSRs, etc.
From reference library to submission-ready draft, in hours, not weeks.
Open a template.
Choose from 40+ templates shaped to ICH E3, FDA, journal standards and more. Each template carries its own section structure, voice instructions, and grounding rules.
Upload your library.
Drag in your study reports, protocols, prior submissions, SAPs, and literature. ProWriter organizes them into a searchable, citable reference library that's scoped to your project and never shared with other users.
Draft, review, lock, submit.
Generate sections grounded in your library. Review with your team using role-based access. Export to .docx or PDF. Every change logged in an immutable audit trail.
One subscription. Multiple Tools.
One workspace.
Templates
Purpose-built models for CSR, CSP, IB, NDA, ICF, patient narratives and more. Each template is paired with a model fine-tuned on that exact document type, structure, voice, citation handling, agency idiom, all baked in.
Read more →On Demand Experts
Book vetted regulatory experts, medical writers, and biostatisticians by the hour, straight from inside the app.
Read more →Secure Messaging
HIPAA-grade, end-to-end encrypted DMs and channels. Your Slack alternative for regulated work.
Read more →Electronic Notebook
A versioned lab journal, bench observations, protocols, figures, with full 21 CFR Part 11 audit trail.
Read more →Teams
Built for regulatory and clinical groups, shared libraries, locked sections, role-based access, and an immutable audit trail your QA lead can export on demand.
Read more →Auto Update
Revise writing faster. Highlight text, describe the change, and review tracked edits inline.
Read more →Data Analysis
Export-ready stats and tables directly from your data.
Read more →Data Visualization
Publication-ready figures, forest plots, KM curves, and TLFs.
Read more → Built for regulatory science.
Not adapted from a general-purpose AI.
ChatGPT, Copilot, and general AI assistants are not HIPAA-compliant by default, are not grounded in your reference library, do not understand ICH E3 structure, and cannot produce an audit trail. They are powerful tools, for tasks that don't go to an FDA reviewer.
ProWriter was built specifically for the documents that do.
Your data is protected. Always.
Three commitments, none of them aspirational, all of them audited.
Industry-standard encryption.
Your data is encrypted at rest (AES-256) and in transit (TLS 1.3). We perform regular third-party security tests to ensure best industry standard encryption.
No model training, ever.
We never use your inputs or outputs to train models. Your IP, methods, drafts, raw data stays yours. Contractually and architecturally.
No data sharing.
AI chat records are deleted when you navigate away from a document. We don't sell, rent, or share user-uploaded data with third parties.
Simple, transparent. Try before you commit.
Create a free account and explore ProWriter. Upgrade to Individual plans at $24.99/mo or set up your Team workspace for $39.99/seat/mo. Save one month when you bill annually.
Frequently asked.
Check out ProWriter
Book a demo with our regulatory writing team. We'll show you a live section drafted from your document type, grounded in your sample reference library.