The problem
Stop paying contractors to format tables the week before submission.
Most regulatory writers at small biotechs pay someone to clean up document formatting before every submission — tables that need to meet FDA Technical Conformance Guide standards, cover letters that keep getting sent back, styles that drift across contributors. It is the most expensive, most avoidable problem in the stack.
"The cost they offset was a contractor."
Lumen Bioscience · First Enterprise customer
Chrona Pro handles it. It runs inside your existing Word workflow, reads your document as you write, and tells you exactly what needs fixing before submission, not after the IR.
What it does
Three things that matter before every filing.
Six checks and tools, all running inside Word's sandbox. Your document content never leaves Word.
Cover letter validator
All four required elements per FDA Tech Guide §4 — contacts, regulatory description, submission size, and AV software name and version. Checked in under a second.
IND table formatting
Tables formatted to FDA submission standards — borders, header rows, font sizes, cell padding, caption placement — in one click. Across the whole document or one table at a time.
Custom rules
Describe a check in plain language, get a taskpane button. Terminology enforcement, scan rules, search rules — your organization's standards, applied automatically.
IND section headings
Browse and insert CTD section headings from the taskpane. Numbered heading hierarchy applied automatically.
Reviewer's guide linter
Structural checks for outline format, hyperlink count, PED table presence, and duplicate TOC content — the most common reviewer's guide failure modes.
Nothing leaves your document
Every check runs in Word's sandbox. Findings are yours to act on. Chrona Pro never modifies your content without your explicit action.
How it works
Inside Word. Read-only on your content.
Install from the Microsoft Marketplace.
One-click install. Works in Word desktop and Word Online. IT can deploy organization-wide via M365 Centralized Deployment.
Open your document. The Chrona Pro tab is on your ribbon.
Run a validator or apply formatting. Results appear inline as finding cards on the page you're working on.
Submit with confidence.
Every check runs in Word's sandbox. Chrona Pro never modifies your content without your explicit action.
Pricing
$99/year. No procurement required.
Individual license, billed annually. Available directly on the Microsoft Marketplace — no sales call, no contract, no IT ticket required for an individual install.
Free
$0
Full document formatting for individual regulatory writers.
- ✓ One-click table formatting
- ✓ Custom table colors + saved profiles
- ✓ IND Section Headings pack
- ✓ Heading + body text styles
Pro
$99 / year
Advanced tools and regulatory confidence for IND contributors.
- ✓ Everything in Free
- ✓ Cover letter validator (Tech Guide §4)
- ✓ Reviewer's guide linter
- ✓ eCTD formatting conventions
- ✓ FDA terminology enforcement
- ✓ Custom scan, search + format rules
- ✓ AI-powered rule generation
Enterprise
Contact us
For regulatory teams managing multi-sequence INDs. Pro included at no extra cost.
- ✓ All Chrona Pro capabilities
- + Enterprise findings in your ribbon
- + Cross-document consistency checks
- + Section sign-off + audit ledger
- + 21 CFR Part 11 compliance
- + Tenant residency
What's next