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.
87% less drafting and review time per CSR section.
A biopharma team developing CAR-T cell therapy for AML compared ProWriter with its in-house workflows, manual drafting and a generic AI tool, across five ICH E3 CSR sections. Each section was timed from reference gathering to hand-off for CMO sign-off, human review included.
See it on your own documents: book a demo →- Median reduction in time per section vs. manual drafting
- 87%
- Median reduction in time per section vs. manual drafting
- Median time per section with ProWriter, vs. 4.25 hours manually
- 27 min
- Median time per section with ProWriter, vs. 4.25 hours manually
- Approximate reduction vs. a generic AI tool (about 1.5 hours per section)
- ~70%
- Approximate reduction vs. a generic AI tool (about 1.5 hours per section)
- Redaction needed. The generic AI tool workflow took 15 minutes to 5 hours per document.
- 0
- Redaction needed. The generic AI tool workflow took 15 minutes to 5 hours per document.
One company, five CSR sections, March 2026; four participants (the client's CMO, senior and associate medical writers, plus a ProWriter medical writer, who drafted the ProWriter versions). The client's senior medical writer ran QA/QC and the CMO signed off every version. Not a controlled trial. Redaction time is excluded, and generic AI tool times are approximate, as reported by the client's team. Customer name withheld on request.
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 $24.99/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.