The error that passes every review.
We catch it.
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.
● Trained on 34,201 FDA-approved drug label documents
Advise to report any signs of infection immediately.
Titrate based on renal function and patient response.
FDA-approved drug label documents in training corpus
vs. Grammarly's 7/10 on pharma context error detection*
Minimum cost of a labeling CRL*
Offline — zero data egress, runs inside your environment
* Internal benchmark across curated pharma context errors; methodology available on request. CRL figure illustrative: 6-month launch delay at ~$1M/day.
The errors that slip through every review
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.
Advise patents to report any signs of infection immediately.
patents → patients
Patient instruction error — FDA deficiency letter risk
Titrate does based on patient renal function and weight.
does → dose
Dosing instruction corrupted — prescribing error risk
Contraindicated in patients with hepatic inflammation (Child-Pugh B or C).
inflammation → impairment
Wrong contraindication category — patient safety impact
Store at controlled room temperate (20°–25°C / 68°–77°F).
temperate → temperature
FDA-defined storage condition absent — recall risk
Contraindicated in patients with placenta group in clinical trials.
placenta → placebo
Clinical trial exclusion criterion corrupted
Administer 10 mg orally one daily with or without food.
one → once
Dosing frequency ambiguous — patient harm risk
Pharmaceutical context intelligence, not spell check
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.
Submit your document
Upload any pharmaceutical document — Package Insert, SmPC, Patient Leaflet, NDA submission text — in any common format. Everything runs offline inside your environment.
Context engine analyzes
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.
Errors flagged with evidence
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.
Your live, FDA-published labels — already checked
Context errors don't only happen before submission. ContextRx continuously scans published drug labels and can show you the errors already live on your products today — before a regulator, pharmacist, or competitor finds them. Pre-submission review catches what's coming; published-label monitoring catches what's already out there.
Adults: take one tablet by mouth once every six ours, not to exceed 4 doses in 24 hours.
→ hours
Live in market. Surfaced by ContextRx scan of DailyMed corpus.
Avoid in patients with severe hepatic inflammation (Child-Pugh C).
→ impairment
Live in market. Surfaced by ContextRx scan of DailyMed corpus.
Store reconstituted suspension at controlled room temperate.
→ temperature
Live in market. Surfaced by ContextRx scan of DailyMed corpus.
Run ContextRx on your document
Paste regulatory document text directly. ContextRx runs a context error scan — results in seconds.
This web demo is a hosted sandbox; the deployed product runs fully offline inside your environment with zero data egress.
Book a Demo or Request Access to ContextRx.
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.
What to expect
- 1We respond within one business day
- 2We start by understanding your document workflow, not delivering a demo script
- 3You can test ContextRx on your own regulatory documents in a secure, offline environment
- 4If ContextRx is not the right fit, we will tell you
Fits inside your existing review environment
ContextRx is built to sit inside your existing review environment without disrupting it. The architecture is offline-first and deployment-agnostic — it runs within your validated environment, connects to your document management infrastructure, and produces audit-ready output without any data leaving your system. No cloud dependency. No workflow rebuild.
ContextRx fills the gap every other tool leaves open
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 |
Priced at a fraction of one reviewer-hour
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.
Individual Writer
billed annually
- ✓Unlimited document scans
- ✓Offline desktop app
- ✓1 user license
- ✓Email support
- ✓14-day free trial
Team
billed annually
- ✓All Individual features
- ✓Team admin dashboard
- ✓Usage analytics
- ✓Priority support
- ✓14-day free trial
Professional
billed annually
- ✓All Team features
- ✓API access
- ✓GxP validation package
- ✓21 CFR Part 11 audit trail
- ✓SSO / SAML
Enterprise
- ✓On-premise server deployment
- ✓Full GxP IQ/OQ/PQ docs
- ✓Dedicated CSM + SLA
- ✓Custom dictionary training
- ✓Multi-site global licensing
Per-document API pricing available for CROs and integrations — from $3.00/doc at volume. See API pricing →
One missed error. $180M in delayed revenue.
A single FDA Complete Response Letter citing labeling errors delays market launch 6–18 months. ContextRx costs less than 6 minutes of a regulatory writer's time per document.
Minimum cost of a labeling CRL*
Regulatory-writer time equivalent per document at $3–$12/doc
Offline — no data leaves your environment. Ever.