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CMC Automation

One solution for eCTD: Module 3 & Annual Reports

Accelerate your CMC Development and Annual Reports Generation with our end-to-end automation solution. Accelerate submissions with automation, traceability, and audit-ready compliance. Unify ingestion, CMC modules, PFDs, and authoring into a single source of truth—then publish both development Module 3 and commercial Annual Reports as eCTD sequences. Supports small molecules, biologics, vaccines, and CGT. 
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CMC Automation
Module 3 & Annual Reports

Bridging Fragmented Workflows

Teams lose time collating data across QMS/LIMS/SharePoint, re-entering values, and reconciling versions. Mushroom automates extraction → structuring → authoring with full traceability—so your eCTD stays consistent from development to commercial lifecycle updates. 

Solution Benefits

Compliance

Authoring aligned to FDA/EMA eCTD formats and organization templates (e.g., ICH M11).

Consistency

Annual Reports reuse the approved Module 3 as a single source of truth with current-year updates.

Speed

Auto-compile drafts from validated data & prior filings.

Traceability

Link every value back to origin with audit trails

Scalability

Multi-site, multi-modality, DS/DP version control.

Lifecycle: Development and Commercial

Development eCTD (Module 3)

  • Ingest & normalize assay/PPQ/release/stability/risk 
  • Map to CMC modules (3.2.S / 3.2.P) with templates 
  • PFDs linked to specs/IPC & facility fit 
  • Version matrix: DS/DP by site (e.g., Site I DS V1 / DP V2) 
  • Generate Module 3 drafts → eCTD sequence 
Development eCTD (Module 3)

Benefits

Seamless Integration (1)
Interactive PFDs
DS/DP steps linked to specs/IPC & facility fit; drag, connect, annotate.
Regulatory Expertise
PPQ & Release
Plan/runs, lots, and specs mapped into Module 3 sections.
Module 3 Authoring
Module 3 Authoring
3.2.S / 3.2.P generation with readiness checks; export as eCTD sequence.
cMC

Commercial eCTD (Annual Reports)

  • Reuse approved Module 3 + current-year data.
  • Auto-summaries: stability trends, deviations/CAPA, spec/site/version changes.
  • Change history & RFI roll-ups.
  • Export report packages → eCTD sequence.

Benefits

Annual Reports Automation
Annual Reports Automation
Assemble from approved Module 3 + current-year data & prior filings.
Smart Summaries
Smart Summaries
Stability trends, CAPA/deviations, spec & site/version changes.
Export Traceability
Export & Traceability
DOCX/PDF & eCTD sequence with full lineage to underlying records.

Real-World Use Case

Business Challenge

A pharmaceutical manufacturing company faced recurring delays and inefficiencies in CMC submissions. Over 4,000 manual hours were spent annually across 100+ products due to fragmented data, manual compilation, and inconsistent templates.

Business Challenge
  • Automated Data Extraction & Structuring: Integrated QMS and LIMS to auto-ingest and standardize critical CMC data.
  • Dynamic Module 3 Generation: Enabled one-click eCTD draft creation using predefined templates for all modalities.
  • Change Tracking & Version Control: Automated document update detection with streamlined review workflows.
  • System Integration: Connected Regulatory, Quality, and Manufacturing teams through Salesforce and Document Center integration. 
  • Time Savings: Reduced CMC preparation time.
  • Enhanced Accuracy: Minimized manual errors, ensuring data consistency across all modules.
  • Regulatory Readiness: Delivered audit-ready, submission-compliant documents for global agencies.
  • Scalability: Supported automation for all products and modalities, improving visibility and cross-functional collaboration. 

Ready to see your data flow into eCTD?

Bring sample documents—we’ll show ingestion → modules/PFDs → Module 3 & Annual Reports. 

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