Now available on the Microsoft Marketplace
Chrona Pro is a Microsoft Word add-in that validates your FDA cover letter, formats tables to submission standards, and runs custom rules — without leaving Word. $99/year.
Pick your rules and table styles. Install to Word in minutes. Or get the standard build on the Marketplace →
Already have a Chrona Pro account? Sign inWorks in Word desktop Word Online M365
02 — The wedge
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's the most expensive, most avoidable problem in the stack.
Chrona Pro is the Word add-in that 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.
Data point
The cost they offset was a contractor.
Lumen Bioscience First enterprise customer
03 — Inside Word
01Cover Letter Validator
For every IND submission, the FDA Technical Conformance Guide requires four specific elements. A missing one doesn't reject your submission — it pauses the review clock with an Information Request.
The four required elements: named regulatory and technical contacts with email addresses, a regulatory description of the submission, an approximate submission size, and a virus-free statement naming the antivirus software, version, and company.
Chrona Pro checks all four. Every time. In under a second.
Caption
Table Style
Symbols
Dear Sir or Madam: Lumen Bioscience, Inc. respectfully submits this Investigational New Drug Application for tessera-9, a recombinant spirulina-derived therapeutic protein, for the treatment of inflammatory bowel disease.
The submission has been scanned with Symantec Endpoint Protection (version not specified) and found to be free of viruses.
The estimated submission size is approximately [size pending]. Regulatory and technical contacts are listed below.
Regulatory contact: Margaret Otieno · m.otieno@lumen.bio
Technical contact: Jin Park · j.park@lumen.bio
We look forward to the Agency's review and welcome any questions regarding this submission.
Sincerely,
Margaret Otieno
VP Regulatory Affairs · Lumen Bioscience, Inc.
The Cover Letter Validator is the first of several built-in validators in Chrona Pro. New checks ship with each Marketplace release.
02Table Formatting
Tables in IND submissions need specific borders, header rows, font sizes, cell padding, and caption placement per the FDA Technical Conformance Guide.
When five contributors write five sections over six months, every table ends up slightly different. Chrona Pro normalizes them.
Select a table or run the formatter across the document. Chrona Pro applies the standard, shows you what changed, and leaves a clean document ready for submission.
CaptionTable Style
SymbolsLinearity was demonstrated over the range of 25–125% of nominal concentration. Validation results are summarized in Table 3.2.P.5.4-2.
| Parameter | Result | Acceptance | Pass |
|---|---|---|---|
| Linearity (r) | 0.9994 | ≥ 0.999 | Yes |
| Accuracy (% recovery) | 99.4 ± 1.2 | 98–102% | Yes |
| Repeatability (% RSD) | 0.7 | ≤ 2.0% | Yes |
| Range | 25–125% | per protocol | Yes |
Accuracy was evaluated at three concentration levels with mean recovery within the acceptance range across all replicates.
03Custom Rules
Every regulatory team has house standards beyond the FDA Tech Guide. Codify them and run them as automated checks alongside the built-in validators.
Preferred terminology, prohibited abbreviations, required section headers, organization-specific formatting — custom rules let you express any of these as a structured check.
Rules are defined as structured JSON and executed by a fixed, audited interpreter inside Word's sandbox. Your document content never leaves Word. Nothing is sent anywhere without your explicit action.
04 — How it works in your workflow
01 · Install
Available on the Microsoft Marketplace (formerly Microsoft AppSource). Install in one click. Works in Word desktop and Word Online. Your IT team can deploy it organization-wide via M365 Centralized Deployment.
One-click install · Marketplace verified
02 · Open your document
Open any IND document. The Chrona Pro tab appears in your ribbon next to Home and Review. Run a validator or apply formatting. Results appear inline as finding cards on the page you're working on.
Inline findings · no second window
03 · Submit with confidence
Every check runs in Word's sandbox. Your document content never leaves Word. The finding is yours to act on — Chrona Pro never modifies your content without your explicit action.
Sandboxed · explicit action required
05 — Pricing
Individual license, billed annually. Available directly on the Microsoft Marketplace — no sales call, no contract, no IT ticket required for individual install. If your organization already uses Chrona Bio Enterprise, every seat includes Chrona Pro at no additional cost.
For individuals
Chrona Pro
$99 / year
Annual license · billed once · cancel anytime
Builder runs in your browser · install to Word in minutes
Or get the standard build on the Marketplace →For teams with Enterprise
Included with Chrona Bio Enterprise
Included every seat
Every Enterprise seat includes Chrona Pro · no additional license
Already on Enterprise? Pro is already in your ribbon.
Chrona Pro is a Microsoft Word add-in for regulatory writers preparing FDA IND submissions. Available on the Microsoft Marketplace.