Mark Richardson

Mark Richardson experienced regulatory affairs professional with a solid background in the development of small molecule, recombinant, cell and gene therapy products in both pharma and CRO sectors over the last 20 years. My knowledge of regulatory expectations and quality compliance across this spectrum allows me to advise and execute at the technical and strategic levels from detailed data requirements to full regulatory development plans. This knowledge and expertise has been applied to related areas such as regulatory due diligence, litigation, programme gap analysis and development of SOPs and study report systems.