Regulatory Intelligence

Regulatory intelligence that works where your documents already live.

Chrona scans your regulatory submissions for cross-module inconsistencies, tracks sign-off readiness across every contributor, and builds an inspection-ready audit trail — without touching a single file.

The reality

Regulatory submissions are hundreds of pages across dozens of documents, written by different people over months. The dose expression in one module doesn't match another. A compound code your CMC team stopped using is still in three sections. A cross-reference points to a section that was restructured in the last amendment.

Nobody catches this until the review team — or FDA — does.

The tools that exist are either enterprise platforms that cost six figures and take months to implement, or they're Excel trackers and good intentions. If your submission deadline is 8 weeks out, neither option works.

Chrona reads your documents where they live — SharePoint, network drives, wherever your team works. It never modifies a file, never copies your content, and never asks you to change your workflow. You get intelligence. Your team keeps control.

1

Connect your document library

Point Chrona at your SharePoint site, network share, or document repository. No migration, no data model, no IT project.

2

Scan for issues

AI-powered consistency checks run across your entire document set. Results stream in real time, linked to exact source locations.

3

Track readiness

One dashboard showing every finding, every sign-off, every open item. A single readiness score your lead can trust.

Intelligence for every stage of your submission.

🛡

Find what reviewers will question.

Automated scans across your full document set catch the inconsistencies that cause delays. Every finding links to the exact source. Dismiss with documented rationale. Re-scan only when files actually change.

Abbreviation conflicts Compound code variants Dosing discrepancies Cross-reference gaps Population mismatches
Dose conflict detected
"150 mg" in Module 2.7.1 vs "150 mg/kg" in Module 5.3.5
M2.7.1 p.23 · M5.3.5 p.114
Undefined abbreviation
"PFS" used 14 times, never defined
M2.5, M3.2.P.8, M5.3.5
Broken cross-reference
"See Section 3.2.P.4" → section does not exist
M2.3 p.8
Compound code — consistent
"ABC-1234" used uniformly across 23 documents

Know exactly where you stand.

One dashboard showing every open comment, every pending tracked change, every section sign-off across the entire submission. No more chasing contributors over email to ask "did you finish your section?"

Section sign-offs Open comment tracking Readiness score Staleness alerts
78%
Submission readiness
Sign-offs
Comments
Changes
Findings

Navigate your submission like one document.

Full explorer with version history across every submission sequence. See what changed in each amendment. Compare any two versions side by side. Stop opening dozens of files to find one paragraph.

Version matrix Inline comparison Document viewer Change tracking
Seq 0000
Seq 0001
Seq 0002
M2.5 Overview
v1
v2
M3.2.P.8
NEW
v2
M5.3.5
v1
v2
v3
M2.7.1
NEW
v2
v3
Coming: Intelligent analysis of FDA information requests — mapped to the sections that need attention, grounded in your own submission history and real-world precedent.

Inspection-ready from day one.

Every decision is auditable

Every finding dismissed, every override rationale, every sign-off — immutably logged with full attribution. SHA-256 checksums on every record.

AI results are fully traceable

Every scan result is linked to the exact prompt version, model version, and document state that produced it. Reconstruct exactly how Chrona reached its conclusions.

Readiness snapshots are sealed

When your team declares "ready to submit," Chrona captures the exact state of every finding, sign-off, and document hash — and locks it cryptographically.

Your choice of AI provider

Bring your own Anthropic or OpenAI key. Every LLM call sends only structured excerpts — never full documents, never filenames, never patient data.

Chrona is designed for 21 CFR Part 11 environments. Our compliance architecture is documented and available to your quality team on request.

Leveling the playing field.

Large pharma has decades of institutional memory about what regulators expect and how to navigate the process. Small biotechs don't — and they pay for that knowledge gap in time, capital, and delayed therapies.

Chrona exists to close that gap. We're building intelligence that learns from every submission, every interaction, every consistency pattern — so that a 15-person biotech preparing their first filing has access to the same regulatory instincts that a $50 billion pharma company takes for granted.

Preparing a regulatory submission?

We're onboarding teams now.

Book a Demo →