Accelerate eCTD Submissions with Intelligent Document Processing
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- CMC Module 3 authoring
Module 3 narratives that don't take weeks to write.
Your CMC data is already in your LIMS, EDMS, and SharePoint – it’s the extraction, formatting, and narrative writing that burns the time. NuMantra pulls your source data, drafts the sections, and hands your team a reviewer-ready Module 3.
- 3.2.S drug substance
- 3.2.P drug product
- 2.3 QOS
- Stability summaries
- Impurity profiles
- 21 CFR Part 11
Less prep time
Regions in one workflo
Compliant audit trail
Draft agent writes Module 3 sections from your LIMS data and approved language library. Same-day first draft.
When a specification changes, every dependent section — 3.2.S, 3.2.P, QOS — is flagged automatically.
FDA, EMA, PMDA, and Health Canada rule sets applied at export — no manual reformatting between markets.
Insert pre-approved language blocks. Every reuse is traceable to its source document and sign-off date.
How Our eCTD Submission Software Works
Ingest
Structure
Validate
Publish
Track
Our agentic AI orchestrates specialized Search, Draft, Validate and Publish agents to eliminate manual steps without breaking your standard operating procedures.
Next-Generation Regulatory Operations Software
Powered by agentic AI and real-time validation, NuMantra augments or seamlessly replaces legacy RIM systems. Our platform ensures flawless compliance across FDA, EMA, Health Canada eCTD and PMDA frameworks.
Intelligent Features for Seamless eCTD Publishing
- XML Validation Software & Labeling: Author PLR and labeling with validated XML, featuring auto-populated CMC (Module 3) narratives.
- AI Document Classification: Automatically structure, extract and classify inputs directly into the correct CTD sections.
- Hyperlink Validation & eCTD Readiness: Run instant inline checks for bookmarks, hyperlinks, metadata and granularity before compilation.
- Seamless API Integration: Connect effortlessly with Veeva Vault, SharePoint and external publishers.
Step 01
Ingest & Structure
- Automatically map Word and PDF inputs using advanced intelligent document processing to classify documents into standard CTD sections.
Step 02
Validate in Real Time
- Execute automated hyperlink validation, cross-referencing and metadata integrity checks on the fly.
Step 03
Assemble & Publish
- Package regional sequences automatically. The system switches regional rule sets (FDA/EMA/HC/PMDA) instantly to export flawless eCTD backbones.
Step 04
Track & Improve
- Monitor issue trends, analyze content re-use and maintain strict governance with audit logs and e-signatures.
Why Regulatory Affairs Teams Choose NuMantra
50-70% Faster Prep
Driven by intelligent workflow automation and semantic reuse.
Fewer Late-Stage Errors
Inline validation catches critical errors long before the final compile.
Global Agility
Locale-aware rule sets and templates keep your submissions globally compliant.
Phaseable RIM Replacement
Integrate with your existing software stack now and consolidate later.
Lower Vendor Sprawl
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
Frequently Asked Questions
What is intelligent document processing in regulatory submissions?
Intelligent document processing (IDP) uses AI to automatically extract, classify and normalize unstructured data from Word and PDF files, converting them into structured formats required for compliant eCTD submissions.
How does agentic AI improve the eCTD process?
Unlike standard AI, agentic AI acts autonomously within your parameters. NuMantra’s agents work in concert to search for approved language, draft narratives, validate links and publish sequences, drastically reducing the manual workload for regulatory affairs teams.
Does NuMantra include hyperlink validation?
Yes. Our platform includes built-in, real-time hyperlink validation and XML validation, ensuring that all bookmarks, metadata and cross-references are structurally sound before you generate your final submission.
Which global health authorities does your software support?
NuMantra’s regulatory submission software dynamically switches regional rule sets to support the FDA, EMA, PMDA and Health Canada eCTD requirements.
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