Digital CMC Centre for Excellence in Regulatory Science and Innovation (CERSI)
Driving the digital transformation of medicines development and manufacturing.
The Digital CMC CERSI brought together expertise from industry, academia and regulation to explore how digital technologies could support the future of medicines development and regulatory science.
Led by CMAC, the project focused on accelerating the adoption of digital tools including AI, machine learning and predictive modelling within Chemistry, Manufacturing and Control (CMC).
Funded through the Innovate UK CERSI programme in partnership with the Medicines and Healthcare products Regulatory Agency (MHRA), Office for Life Sciences and the Medical Research Council (MRC), the project formed part of a wider UK initiative supporting innovation in regulatory science.
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The pharmaceutical sector is undergoing rapid digital transformation, but regulatory adoption of advanced digital technologies remains complex.
The project explored key challenges including:
Regulatory readiness for AI and predictive models
Data quality, integrity and security
Standardisation and confidence in digital tools
Skills and expertise gaps across the sector
Translating innovation between academia, industry and regulators
Supporting more sustainable medicines development
As medicines development becomes increasingly data-driven, new approaches are needed to ensure innovation can be adopted safely, efficiently and with regulatory confidence.
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The Digital CMC CERSI created a collaborative environment where industry, regulators and academia could work together to explore practical 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.
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The mission of the Digital CMC CERSI was to help accelerate the safe and effective adoption of digital technologies in medicines development and manufacturing regulation.
Through collaboration, training and knowledge exchange, the project aimed to support:
Faster access to medicines
More efficient development pathways
Increased sustainability in pharmaceutical manufacturing
Greater confidence in digital technologies across the sector
Outputs and Resources
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Monet Goode
FOUNDER
With a vision for building something meaningful, our founder brings a blend of big-picture thinking and hands-on experience.
They set the tone for everything we do. -
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Emmett Marsh
SALES MANAGER
Focused, approachable, and driven by results, our sales manager is all about building strong relationships. They help connect people to the right solutions—with clarity and care. -
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Eleanor Parks
MARKETING DIRECTOR
Creative and strategic in equal measure, our marketing director brings fresh ideas to every campaign. They turn insights into action and help our message resonate with the right audience. -
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Karl Holland
CUSTOMER SERVICE MANAGER
Friendly, attentive, and always ready to help, our customer service manager ensures every interaction is a positive one. They keep communication clear, timely, and human.
