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As Lex Regulatory Ltd, I work as an independent regulatory consultant, specializing in CMC regulatory affairs (CMC RA) for gene and cell therapy products (ATMPs). I apply knowledge and experience acquired over 25+ years to the complexities and challenges of these types of products, which is very rewarding.

Lex Regulatory Ltd emerged from a love of the job and extensive experience in CMC RA, including CMC RA lead for the Strimvelis (gene therapy) marketing application (MAA). For about 10 years I have focused solely on gene/cell therapy products.

A large proportion of my experience is with genetically modified (GM) cell-based products but I have also worked on non-GM cell therapies and in vivo viral vectors. My knowledge spans from early phase (first-in-human) to marketing applications and post-authorization and various global markets, particularly USA and Europe.
Previous areas of work included antibody drug discovery, molecular biology-based research (PhD) and science policy. Over many years I have developed an in-depth understanding of the regulated environment for biological medicinal products and associated science and technology.

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