Digital CMC Centre for Excellence in Regulatory Science and Innovation

Enabling regulatory-ready digital transformation in pharmaceutical development and manufacturing

The challenge

Fewer than 15% of digital tools reach regulatory submissions. We seek to change that through practical frameworks, shared workflows, and cross-sector collaboration.

Digital and AI-enabled tools are transforming pharmaceutical development and manufacturing. Yet adoption in regulated Chemistry, Manufacturing and Controls (CMC) activities remains uneven, held back not by technology, but by uncertainty around regulatory expectations, fragmented guidance, and capability gaps.

  • The Digital CMC Centre for Excellence in Regulatory Science and Innovation (CERSI) is a collaborative initiative led by CMAC at the University of Strathclyde and supported by the Medicines and Healthcare products Regulatory Agency (MHRA).

    We provide a neutral, pre-competitive environment for industry, regulators, and academia to advance the responsible adoption of digital and AI-enabled tools in pharmaceutical CMC.

    • Accelerate safe and effective digital transformation in pharmaceutical CMC

    • Develop practical regulatory science frameworks and workflows

    • Build shared understanding between industry, regulators, and academia

    • Support harmonisation, transparency, and lifecycle-based governance

    • Enable sustainable and resilient medicines manufacturing

  • The Digital CMC CERSI has created a collaborative environment where industry, regulators and academia can work together to explore new approaches to digital regulatory innovation.

    The project focused on:

    Developing agile regulatory frameworks - Supporting more standardised and forward-looking approaches for digital CMC and regulatory decision-making.

    Advancing digital and AI-enabled technologies - Exploring the application of AI, machine learning, hybrid models and predictive tools through collaborative case studies and engagement activities.

    Building capability across the sector - Delivering training, workshops, webinars and knowledge-sharing activities to support the wider adoption of digital technologies.

  • The responsible adoption of digital predictive tools could enable:

    • Faster patient access to medicines

    • More robust and resilient manufacturing

    • Improved sustainability

    • Better process understanding

    • Reduced development costs and timelines

    • Stronger supply chain agility

    Achieving these benefits requires trusted, transparency, and regulator-ready approaches that maintain patient safety and product quality.

    The Digital CMC CERSI exists to help bridge the gap between innovation and implementation.

Outputs and Resources

The Digital CMC Regulatory Lifecycle (DCRL) Framework

A risk‑based structure that supports the management of digital predictive tools across the pharmaceutical CMC lifecycle, enabling confident, regulatory‑ready adoption.

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The Digital CMC Regulatory Lifecycle (DCRL) Workflow

A guided sequence for the development, validation, and regulatory use of digital and AI-enabled tools across their full lifecycle.

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  • SkillsFactory

    Hosting training resources including interactive courses, webinars, and discussion forums for the digital medicines manufacturing community.

    Learn with us

  • Virtual Expert for Regulatory Assistance

    VERA is an AI-enabled support platform designed to assist with interpretation of regulatory expectations and framework implementation.

    Explore insights

  • Digital CMC Sandbox

    A collaborative environment for testing, evaluation, and demonstration of digital regulatory science approaches.

    Discover more

  • Digital Tools in CMC Survey

    A cross-sector survey exploring the use and regulatory challenges of digital and AI-enabled tools in pharmaceutical CMC to help identify priorities for advancing regulatory science.

    Review our results

  • Case studies

    Demonstrating how the DCRL framework can be applied in real-world CMC scenarios to support innovation, product quality, and patient safety through practical, regulator-ready examples.

    Read more

Webinars and videos

Papers

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