Features
Everything You Need for Regulatory Operations
Compliance-ready workflows with full audit trails. Automated cross-reference intelligence. Validated infrastructure. All connected.
Five applications, one regulatory platform.
Each one solves a job regulatory teams do every week. They share the same content store, the same audit trail and the same permission model — so work planned in one is publishable from the next.
Submission Planning & Tracking
Build the content plan, assign owners and due dates, and see exactly which documents are holding a filing back — across every application in the portfolio.
Explore Planner →Monitoring, HAQ Readiness & Correspondence
Portfolio-aware guidance monitoring, health-authority question readiness and a single tracked home for HA correspondence — connected to the submissions they affect.
Explore Regulatory Intelligence →eCTD Viewer & Review Platform
Open any sequence in the browser — no client install, no local copy. Navigate the cumulative view, follow lifecycle across sequences and review with the reviewer's own toolset.
Explore Reviewer →Compliant Document Management
Versioning, check-in/check-out, controlled lifecycles and e-signatures — built for regulated content rather than retrofitted onto a general-purpose file share.
Explore EDMS →CCDS Compliance & Deviation Control
Track local labels against the company core data sheet, control and justify deviations, and keep submission due dates visible before they become late.
Explore Labeling →The engine underneath all five.
Publishing, validation, security and integration are platform services — not per-product bolt-ons. Every application inherits them.
eCTD Publishing — 3.x and 4.0
Build, publish and validate sequences for FDA, EMA, Health Canada and 60+ authorities from one dossier.
Multi-Regional Compliance Engine
Region-specific rules, backbones and validation criteria applied automatically per target market.
Preflight & Automated Validation
Catch DTD, PDF and cross-reference defects before the submission reaches the agency gateway.
Dossier Cloning & Lifecycle
Reuse an approved dossier for the next market or the next label update instead of rebuilding it.
PDF Workbench
Bookmarks, hyperlinks and document-level fixes in the browser, on the submission-ready rendition.
AI Document Intelligence
Classification, cross-reference detection and content insight embedded in the authoring workflow.
Enterprise AI Gateway
One governed, auditable path for every AI call — with the model, prompt and result recorded.
Unified Search & Discovery
Full-text and metadata search across the whole dossier library, not one submission at a time.
Veeva Vault & Multi-DMS Integration
Read and publish from the document system you already run — Vault, SharePoint, Box and more.
Workflow Automation
Configurable review and approval routes with entry criteria, tasks and notifications.
Audit Trail & 21 CFR Part 11
An immutable record of every action, with e-signatures that carry meaning and attribution.
Enterprise Security & SSO
SAML and OIDC single sign-on, federated identity and role-based access at enterprise scale.
Security & Compliance Posture
Encryption, validated infrastructure and the controls a qualified regulated system requires.
Multi-Tenant Architecture
Schema-level tenant isolation — the model CROs and multi-affiliate groups need to separate sponsors.
See it against your own submission.
The fastest way to judge a regulatory platform is to point it at a dossier you already know. Bring one, and we will walk it through end to end.
→ Book a walkthrough