ContextRx is the only system built specifically for pharmaceutical regulatory documents. It catches correctly spelled words used in the wrong clinical context — errors that Microsoft Word, Grammarly, and every other standard review tool marks as correct. Trained on 34,201 FDA-approved drug labels. Live and testable today.
These aren't typos. They're correctly-spelled words in the wrong clinical context — invisible to spellcheckers, undetectable by text comparison tools, and catastrophic when they reach the FDA.
ContextRx operates on a fundamentally different architecture from every other tool. It doesn't look for misspellings — it looks for clinically wrong words in the context they appear in.
Upload any pharmaceutical document — Package Insert, SmPC, Patient Leaflet, NDA submission text — in any common format. Everything runs offline inside your environment.
The NLP engine — trained on 34,201 FDA-approved labels — evaluates every token for semantic fit in its pharmaceutical context. Not just spelling: clinical meaning.
Every flagged term is presented with the substitution candidate, the clinical risk category, and the source context — a fully auditable finding ready for regulatory review.
Paste regulatory document text directly. ContextRx runs a context error scan — fully offline, nothing stored, results in seconds.
This demo uses the live ContextRx engine. For full document scanning with 21 CFR Part 11 audit trail:
Launch Full ContextRx Platform →ContextRx is live and testable today. The conversation starts with understanding your documents and your workflow — not a sales pitch. If ContextRx is not the right fit, we will tell you.
ContextRx is designed to integrate with pharmaceutical document management systems — Veeva Vault, Microsoft Word via add-in, and validated QMS environments — without disrupting existing review workflows. Architecture is offline-first and DMS-agnostic by design.
ContextRx does not replace any existing tool. It is the layer that has never existed — catching the one error class that falls through every other check.
| Capability | Microsoft Word | Grammarly | ContextRx |
|---|---|---|---|
| Misspelled words | ✓ | ✓ | ✓ Included |
| Grammar & style | ✓ | ✓ | ✓ Baseline |
| Version-to-version text comparison | ✗ | ✗ | Not in scope |
| Artwork & barcode verification | ✗ | ✗ | Not in scope |
| Pharma context errors (patents→patients) | ✗ Missed | ✗ Missed | ✓ Core capability |
| FDA label domain training | ✗ | ✗ | ✓ 34,201 docs |
| Fully offline / on-premise | ✓ | ✗ Cloud-only | ✓ Built offline-first |
| 21 CFR Part 11 audit trail | ✗ | ✗ | ✓ Full compliance |
| Pharma context error score | n/a | 7/10 | 10/10 |
At $80–$167/hr for a senior regulatory writer, even 2 hours of displaced review time per document justifies $200–$334 in software spend. ContextRx costs far less.