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About Cambridge Scientifix

Cambridge Scientifix Ltd is a consultancy company, supporting: Quality Systems: Assessing Risk and managing Compliance with Regulatory and Quality Systems Pharma Development: Developing robust Regulatory Strategies and submissions to EMA, MHRA and FDA Assay method validation, standardisation and compliance to support CMC development and Quality Compliance Medical Devices and Digital Health products: Technical, Regulatory and Validation advice on ‘Software as a Medical Device’ (SaaMD) and the use of Digital Health Technologies Regulatory compliance to support the use of Real-World Evidence in product development Marc Bailey, Lead Consultant of Cambridge Scientifix Ltd Dr Marc Bailey has extensive senior-level regulator experience gained from his work as the former Chief Science, Research and Innovation Officer of the Medicines and Healthcare products Regulatory Agency (MHRA). Marc was responsible for UK Medicines and Medical Device Regulation with particular emphasis on the early stages of Regulatory Support and Scientific Advice for products in the Discovery, Pre-Clinical and Clinical Trial phases of development. Marc established and lead Risk Management Systems to ensure Quality System Compliance including ISO 9001, 17025, 13485 and GLP. Marc was also the project leader for the Innovative Devices Access Pathway (IDAP) and Innovative Licencing and Access Pathway (ILAP) and responsible for supporting drug-device combination products. Marc has deep knowledge of MHRA, EMA and FDA regulations and brings a unique understanding, from the perspective of a regulator, to pharmaceutical development - ensuring his clients have the greatest chance of success. Marc has worked in Digital Health on both Clinical and Wellness applications and holds patents on the use of wearables and IT to monitor Health and Wellness. At MHRA Marc supported the development of regulatory frameworks for the use of AI and digital therapeutics in healthcare.

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