Reconstruct the current state
Move across sequences and lifecycle operations without manually piecing together what is current.
RegCon Navigator · eCTD viewer + AI assistant
Review eCTD submissions faster—with lifecycle context and built-in AI.
Navigate complete submission lifecycles, find documents instantly, verify submission integrity, and use AI to answer questions across your eCTD—all in one workspace.
14 days · No credit card · Sample submission included
ICH + US regional viewsRender the context reviewers need
PDF + XML + Word viewingOpen linked content in tabs
Leaf-level lifecycle detailFollow new, append, delete, and replace
Desktop + cloud workflowsReview individually or with your team
See it in action
See Navigator work, in two minutes.
A short walkthrough of the software — rendering a submission, tracing a leaf through its lifecycle, and opening the documents behind it.
The review problem
The answer is in the submission. Finding it shouldn’t be the hard part.
Locate supporting evidence
Find the right leaf, open its document, and follow links without losing your review context.
See what needs attention
Surface changed leaves, metadata, comments, and checksum results before they become review friction.
One connected workflow
From sequence to evidence—without switching tools.
Navigator keeps lifecycle structure, document review, integrity signals, and team context together.
1 - Administrative Information1
2 - CTD Summaries10
3.2 - Body of Data200
ATTRIBUTESPRODUCT-NAMEExamplemab Tablets
4.2 - Study Reports7
4.2.1 - Pharmacology3
LEAVES (3)
Examplemab pharmacology summary
Previous pharmacology summary
No Sequences Rendered YetChoose sequences from the panel, then load them into the Viewer.
Built-in AI Assistant
Ask a regulatory question. Move straight to the evidence.
Ask Navigator about the loaded submission, then use its response to reach the supporting sequence, leaf, or document and continue your review.
Example question
“Which sequence contains the current stability protocol, and what did it replace?”
- Answers are grounded in the submission context available to the assistant.
- Supporting references keep the reviewer in control of verification.
- AI assists review; it does not replace regulatory judgment.
AI Assistant
Technical fit
Built around the submission structures your team already reviews.
Current capabilities drawn from the Navigator product and documentation.
ICH and US regional
Render selected sequences and inspect regional content in context.
New, append, delete, replace
Move between changed leaves and the leaves that change them.
PDF and XML
View content in tabs with PDF search, links, bookmarks, zoom, and rotation.
Checksum verification
Verify leaf checksums and identify discrepancies during review.
Sequence and module controls
Select sequences, expand directories, inspect metadata, and find files.
Comments and cloud access
Keep discussion connected to submission context across the team.
Need to verify a specific regional requirement or system configuration? We’ll confirm fit during your evaluation.
Security and AI data handling
Your AI data is yours. Yours only.
We do not use your AI data for model training, and we do not sell it.
01
Your submissions stay secure
Your submissions are protected with encryption and backups in our cloud—or handled by you.
02
Your AI data stays yours
Your AI data is used only to provide the software. It is never used for model training or sold.
03
Two-week evaluation period
Try our software free for two weeks. Use your submissions to see whether RegCon is right for you.
Pricing
Straightforward per-user licensing.
One annual licence per reviewer. Add the AI Assistant when your team is ready — the Microsoft Teams bot comes with it.
eCTD Navigator$400per user / year
The full review workspace — lifecycle views, document viewing, checksums, and comments.
AI IntegrationIncludedfor limited timeAdds the built-in AI Assistant, plus the Microsoft Teams bot at no extra cost.
eCTD BuilderAvailablecontact us for pricingAssemble and publish sequences with a Builder license. Build with AI requires AI access.
Guided free trial
Evaluate Navigator on the workflows that matter.
Navigator Viewer and the built-in AI Assistant are one core product, offered through annual team licensing with enterprise options available.
- 14-day guided trial with no credit card
- Viewer and built-in AI Assistant included
- Prepared sample eCTD environment
- Access within one business day
- Optional 20-minute onboarding session
- 1Create your account
Submit a trial request using your business email.
- 2We prepare the workspace
RegCon confirms your request and provisions the sample environment.
- 3Receive access
Start within one business day and join optional onboarding.
- 4Evaluate the workflow
Render, investigate, review, collaborate, and test the AI Assistant.
Talk with RegCon
Have a question?
Tell us what your team needs to evaluate. We’ll reply with the right product or technical context.
Ready to evaluate Navigator?
Put the full review workflow in front of your team.
Get a prepared sample environment, the built-in AI Assistant, and optional onboarding—without a credit card.