From Documents to Decisions
Automatically, Reliably
From Labeling and CMC to full eCTD—NuMantra automates authoring, validation, and lifecycle management in one modern workspace.
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Intelligent Document Processing
Intelligent Document Processing + real-time validation + agentic AI. Augment—or replace—legacy RIM with an AI-first platform built for FDA, EMA, Health Canada, and PMDA.
Features
- Labeling/PLR authoring with validated XML
- CMC (Module 3) auto-classification & template population
- eCTD readiness scoring & one-click assembly
- Open APIs for Veeva Vault, SharePoint & publishers
How It Works
Ingest
Structure
Validate
Publish
Track
Agentic AI orchestrates Search, Draft, Validate, and Publish agents to remove manual steps—without breaking your SOPs.
Step 01
Ingest & Structure
- IDP ingests PDFs/Word and auto-classifies to CTD sections
- Template population for Labeling XML and CMC narratives
Step 02
Validate in Real Time
- Inline checks for bookmarks, hyperlinks, metadata, granularity
- Regional rule sets switch automatically (FDA/EMA/HC/PMDA)
Step 03
Assemble & Publish
- Sequence packaging with lifecycle integrity checks
- Export Labeling XML, eCTD backbone & validation reports
Step 04
Track & Improve
- Readiness scoring, issue trends, and re-use analytics
- Governance: audit logs, e-signatures, and SoD controls
Why Teams Choose NuMantra
50–70% faster prep
With agentic automation
Fewer late-stage errors
Via inline validation (not after compile)
Global agility
With locale-aware rule sets and templates
Phaseable RIM replacement
Integrate now, consolidate later
Lower vendor sprawl
(Labeling, CMC, eCTD in one workspace)
Integrate with the Tools You Already Use
- Agentic AI: Search/Draft/Validate/Publish agents work in concert
- IDP: classify, extract, normalize across Labeling/CMC/eCTD inputs
- Semantic Reuse: insert approved language/tables with traceability
- Governance: audit logs, e-signatures, SSO, permissions, SoD
- Security: encryption in transit/at rest, granular access policies
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