eCTD in minutes, not weeks

Meet Raven: a platform for classifying, validating, and assembling your FDA submissions automatically. You bring the science, Raven handles the bureaucracy.

See it in action

The end-to-end regulatory specialist

Raven works alongside your team across the whole submission — from the first document to the final validated package.

Reads your documents

Raven accepts files in common formats and uses natural-language understanding to classify content into the correct eCTD sections — automatically, with confidence it can explain.

Builds the structure

The metadata, folder hierarchy, and XML that legacy tools make you edit by hand are generated for you — and validated in real time against FDA, EMA, and NMPA specifications.

Catches what's missing

Missing sections, inconsistent metadata, and noncompliant formatting are flagged before you submit. Raven proposes the fix and applies it on your approval.

Enhances every PDF

Generate inter-document hyperlinks, bookmarks, and annotations across the whole package — no separate PDF editing software, no manual cross-referencing.

Shows its work

Every action comes with a justification: the rule it applied, the source it read, and the confidence behind it. Trust the output because you can see the reasoning.

Ready for every region

Prepare submissions for multiple agencies from a single source of truth. Raven assembles region-specific outputs without you rebuilding the package each time.

Days → minutes
Submission assembly time
3 regions
FDA, EMA & NMPA specs supported
100%
Actions backed by a justification
$0 add-ons
PDF linking & bookmarks built in

Rethink your regulatory workflow

See how Raven assembles a compliant submission in minutes. Book a walkthrough with the Ultraviolet team.

Learn about us