eCTD v3.2.2
Modules 2–5 checked against the ICH DTD.
RegCon Navigator
Review eCTD submissions faster—with built-in AI.
Lifecycles, documents, checksums, and AI answers in one workspace.
14 days · No credit card
ICH + US regional views
PDF, XML, and Word viewing
Leaf-level lifecycle detail
Desktop + cloud
See it in action
See Navigator work, in two minutes.
Render a submission, trace a leaf, and open its documents.
One connected workflow
From sequence to evidence—without switching tools.
Sequences
0000Original application
0001Labeling response
0007Stability update
0015Specification update
0021Annual report
0040Quality amendment
Load 4 sequences
Submission XXX363Nothing rendered yet
ICHUS regional
Choose sequences, then load them.Navigator resolves every lifecycle operation into one current tree.
1/4
Choose the sequences you needThe whole lifecycle or just a few — any combination.
Built-in AI Assistant
Ask a regulatory question. Move straight to the evidence.
Ask about the open submission, then jump straight to the cited sequence, leaf, or document.
- Every answer cites where it came from, so you can verify it.
- AI assists review; it does not replace regulatory judgment.
AI AssistantXXX363 · 6 sequences loaded
Ask anything about the submission you have open.
1/4
Ask about the loaded submissionPlain-language questions about the sequences you have open.
Technical fit
Built around the submission structures your team already reviews.
FDA regional v3.3
Current US regional DTD and headings.
FDA validation criteria
140+ checks, reported by error code.
Study Tagging Files
Read as study records. Authored per module.
PDF, Word, and XML
Opened in place, from any sequence.
Backbone XML output
Builder writes the index and regional XML.
Need a specific requirement confirmed? We’ll check it during your trial.
Security and AI data handling
Your AI data is yours. Yours only.
01
Your submissions stay secure
Encrypted and backed up in our cloud—or handled entirely by you.
02
Your AI data stays yours
Used only to run the software. Never used for model training or sold.
Pricing
Straightforward per-user licensing.
One annual licence per reviewer.
Guided free trial
Evaluate Navigator on your own submissions.
- 14 days, no credit card
- AI Assistant included
- 1Request a trial
- 2Get access within one business day
- 3Start reviewing, with optional onboarding
Talk with RegCon
Have a question?
Tell us what your team needs. We’ll get back to you.
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