Paul Marshall has joined Nerudia as regulatory principal to support customers with medicinal, pre-market tobacco application and Tobacco Product Directive projects.
A former senior pharmaceutical assessor for nicotine and CNS-related products at the U.K. Medicines and Healthcare products Regulatory Agency (MHRA), Marshall will report to Rob Burton, Nerudia head of consultancy and compliance.
Marshall is an experienced regulatory scientist with a broad knowledge of regulatory strategy, chemistry, manufacturing and controls CMC) and drug development. During his 11 years’ service at the MHRA he assessed more than 400 marketing-authorization (MA) applications and 1,000 MA variations covering all dosage forms and regulatory submission routes. He has also been involved in more than 40 formal scientific and regulatory advice meetings with companies developing products.
Marshall has held positions on international committees and working groups, including representing the EU on the International Generic Drug Regulators Program Working Group on Active Substance Master Files, and chairing the European regulatory agencies (CMD/CHMP) working group on ASMFs.
He was a member of the Technical Advice Board, Inspection ad hoc Committee and Expert Assessor for the European Directorate for the Quality of Medicines and Healthcare chemical certification scheme.
He also has a proven track record in managing and developing products, resulting in the successful approval and launch of pharmaceutical products in global markets.
A registered U.K. pharmacist and member of the Royal Pharmaceutical Society, Marshall contributed to the MHRA licensing procedure for electronic cigarettes and other nicotine containing products. He is the Chair of the British Standards Institute Electronic Cigarettes and E-liquids committee and member of European Committee for Standardization TC/437 Working Group 4 on requirements and test methods for emissions from electronic cigarettes and e-liquids.
“We have created one of the largest teams of regulatory and scientific experts in nicotine-containing products in the world, which we will continue to strengthen by appointing top class experts,” said Burton. “We are therefore delighted that Paul has joined Nerudia and it’s a real coup for us to add such a seasoned regulator to our team”.