Part 2: From Lifecycle Chaos to Connected Execution — Digital Twins in CMC
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Part 2: From Lifecycle Chaos to Connected Execution — Digital Twins in CMC

A follow-up to to the previous article, where I explored how product, regulatory, and supply chain complexity in CMC demands connected digital solutions.

The Problem

Across Consumer Health and Pharma, CMC functions operate under constant pressure to maintain compliance, accelerate time to market, and adapt to regional regulations. Yet the supporting data—on formulations, markets, SKUs, sites, and submissions—is fragmented and difficult to trace. In short, data is everywhere—but immediate trust in it is nowhere.

Where Digital Twins Fit in CMC

Digital Twins offer a structured, lifecycle-aware way to unify fragmented views across functions in New Product Development process. They allow teams to work from one version of the product’s digital state—across formulation, regulatory, labelling, and launch. In this prototype, the Paracetamol product lifecycle is modelled through four modular twins.

  • FormulationTwin: Dosage, ingredients, excipients, product specs
  • RegulatoryTwin: Submissions, approvals, market-specific status
  • LabelTwin: Claims, warnings, legal text, localization
  • CommercialTwin: SKU codes, GTINs, launch markets, pack formats

Each twin mirrors a core part of the CMC lifecycle—and evolves as the product does.

Digital Twins Speak the Language of the Business

Real transformation happens when architects & engineers understand how their designs align to business processes, not just infrastructure.

Too often, we chase architectures that look great in PowerPoint. We get excited by tooling, automation, or GenAI trends — and forget what the business user experiences daily.

In CMC, the questions are:

  • “Can this site manufacture the approved version?”
  • “Has the market artwork been updated with new claims?”
  • “Do we know which country launched what and when?”

The best engineers & architects today should not be fluent in just technology. They should be fluent in context.

That’s how we reduce rework, prevent tech debt, and build trust.

Digital Twin Prototype: Built with Purpose (Not Just Tech)

AWS components used:

  • DynamoDB – for twin storage
  • RDS – for simulated MDM
  • API Gateway + Lambda – for lifecycle APIs
  • Quicksight – for dashboards
  • Role-based HTML UIs – for R&D, Regulatory, Labelling, Commercial

It’s lightweight, explainable, and business-facing — not just developer-friendly.

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Architecture Building Blocks

What This Unlocks for CMC

Digital Twins are more than visibility tools.

They enable:

  • Lifecycle automation
  • AI agents that pre-validate submissions and labelling
  • Seamless traceability across formulation, packaging, and launch

And critically:

Digital twins provide the structured foundation for LLM models (possibly RAG-enabled) to answer business questions in plain English — through Agentic AI-powered assistants.

Imagine asking:

  • “Which labels are out of sync with approvals?”
  • “Which SKUs use Formulation B in APAC?”
  • “Is Product X ready to launch in UAE?”

All possible because the data is connected and coherent.

The Big Picture Benefit

Today: Each team solves their slice of the process in isolation, leading to delays, misalignment, and rework. With Digital Twins: Everyone works from the same structured, versioned, and live product lifecycle model.
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Next Steps

In the coming weeks, I’ll be sharing the full working prototype: JSON templates, Lambda APIs, UI stubs, Sample dashboards etc

If you have any suggestions from a CMC end-user perspective or from tech perspective, please reach out — I’d love to connect.

Final Thought

Big-Picture clarity to join the dots is a competitive advantage and today the entry barrier to provide tech solutions is almost non-existent.

And I say this because although I am not a professional developer, I have managed to bring this together by combining analysis skills with the unlimited availability of low/no code toolkits today. We don’t need more impressive architectures and bigger engineering teams. We need tech solutions that are anchored in business, built with empathy, and designed for scale.


🔖 #DigitalTwin #CPG #Pharma #CMC #ProductLifecycle #ArchitectureWithPurpose #AWS #AgenticAI #InnovationExecution #BusinessDrivenTech

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