Overcoming Regulatory and CMC Technical Challenges of Microbiome Product Development

In this white paper we provide a fleeting look at some of the CMC ‘building blocks’ that can be assembled for moving a microbiome product from R&D into first into human studies.

Tim Adetona, Director Drugs Biologics & nutritionals

Tim is responsible for the management of projects involving the design and implementation of global regulatory strategies for the development, evaluation and marketing of nutritional and innovative food-drug borderline products. Tim is equally well versed in regulatory engagements involved with the development of Personal, Health and Beauty Care products (cosmetics, deodorants and antiperspirants), as well as Medical Devices and OTC medicines.

Richard Dennett, Director CMC & Quality

Richard is responsible for the management of projects involving the development of Chemistry Manufacturing and Control (CMC). He provides experienced scientific, Regulatory and Technical expertise for activities like CMC Product Development Strategy, Quality by Design (QbD), Technology Transfer, Comparability, cGMP compliance, Process Validation, Due Diligence, CMC Gap Analysis, Technical and Regulatory 'bridging'​, project management of cGMP outsourcing.

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