CMC Variation Management & Global Submission Orchestration

Every manufacturing change—process optimization, site transfer, supplier qualification—triggers cascading regulatory obligations across 100+ global markets, each with unique classification schemes, documentation requirements, and approval timelines. Manual coordination is slow, error-prone, and constrains manufacturing agility. Post-approval change management is a top priority for regulatory authorities worldwide, and classification errors can lead to refusal-to-file or extended review timelines.

Workflow goal

Automate variation assessment, classification, and multi-market submission preparation to reduce 6-week manual processes to 1 week while ensuring zero classification errors.

Stakeholders

  • Head of Regulatory Affairs

  • CMC Regulatory Specialists

  • Manufacturing Science & Technology

  • Quality Assurance

End-to-End Agentic Flow
1

Change Initiation

  • Ingest proposed manufacturing change description

  • Extract relevant product and process parameters

2

Regulatory Assessment

  • Classify variation by jurisdiction (EU IA/IB/II, FDA PAS/CBE)

  • Identify applicable variation codes and regulatory pathways

  • Determine documentation requirements

3

Documentation Assembly

  • Retrieve relevant documents from Veeva Vault

  • Extract manufacturing data and analytical summaries

  • Generate comparative tables and process flow diagrams

4

eCTD Compilation

  • Assemble submission-ready eCTD sequences

  • Validate structure, hyperlinks, and completeness

  • Perform regulatory compliance checks

5

Multi-Market Orchestration

  • Generate market-specific submission packages

  • Track approval status across all jurisdictions

  • Route deficiency responses to subject matter experts

6

Implementation Coordination

  • Monitor approval timelines with intelligent escalation

  • Coordinate manufacturing implementation post-approval

Platform features highlighted

  • Multi-jurisdictional regulatory intelligence

  • Automated document retrieval and synthesis

  • eCTD validation and quality checks

  • Global submission tracking and orchestration

  • Regulatory affairs review of AI classification

  • Subject matter expert approval of technical dossiers

  • Quality assurance sign-off before submission

  • Read-only access to document management systems

  • Submission preparation time (weeks → days)

  • Classification accuracy rate

  • Multi-market submission velocity

  • Deficiency response turnaround time

  • Approval timeline tracking

DSUR & PBRER Automation