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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About Us
NuMantra Technologies
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.
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
Three Pillars of Regulatory Excellence
Comprehensive automation across the entire regulatory lifecycle
Labeling & SPL
Generate, manage, and publish SPL with schema checks, change control, and audit trails.
CMC (Module 3) Automation
Auto-classify CMC docs, populate templates, and run NLP consistency checks across 3.2.S/3.2.P
eCTD & Lifecycle
Inline validation for bookmarks, hyperlinks, metadata, granularity, and lifecycle—then assemble sequences in a click.
The eCTD
Opportunity
The challenge
Regulatory submissions are complex, time-consuming, and prone to human errors. Teams spend weeks formatting, validating, and compiling eCTD dossiers—leading to costly delays and compliance risks.
The Solution
Our AI-driven platform aims to simplify eCTD submission preparation with:
- Automated document formatting – Ensures compliance with FDA, EMA, and global standards
- AI powered validation – Detects errors before submission to reduce rejections
- Real-time collaboration – Teams can work seamlessly on a centralized cloud platform
- Generative AI assistance – Auto-classification, document hyperlinks, and XML generation
- Reduce submission time by up to 50% and cut down errors by 90%
- Join our early adopters and streamline your regulatory workflow.
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.
Social proof / reassurance
Built for regulated teams: role-based access, e-signatures, validation logs, and audit trails aligned with 21 CFR Part 11 / EU Annex 11 principles.
Secure Access
role-based
Secure Access
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)
Join Our Beta Program
Help Shape the Future of eCTD Submissions
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
