We are delighted to today announce that Dr Paul Marshall has joined our team as Regulatory Principal, to support customers with Medicinal, PMTA and TPD projects. As a former Senior Pharmaceutical Assessor for nicotine and CNS related products at the UK MHRA (Medicines and Healthcare products Regulatory Agency), he brings invaluable experience to the role and will report to Rob Burton, Nerudia Head of Consultancy and Compliance.
Dr Marshall is an experienced regulatory scientist with a broad knowledge of regulatory strategy, CMC (Chemistry, Manufacturing and Controls) and drug development. In 11 years’ service at the MHRA he assessed over 400 Marketing Authorisation (MA) applications and 1000 MA variations covering all dosage forms and regulatory submission routes. He has also been involved in over 40 formal scientific and regulatory advice meetings with companies developing products.
Dr Marshall has held positions on international committees and working groups, including representing the EU on the International Generic Drug Regulators Programme Working Group on Active Substance Master Files (involving regulatory authorities of Australia, Brazil, Canada, Korea, Mexico, Singapore, South Africa, Switzerland, Taiwan, EDQM and WHO), 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 (EDQM) 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 UK pharmacist and Member of the Royal Pharmaceutical Society, Dr Marshall contributed to the MHRA Licensing Procedure for Electronic Cigarettes and Other Nicotine Containing Products. He is the Chair of the BSi (British Standards Institute) Electronic Cigarettes and E-liquids committee and member of CEN (European Committee for Standardisation) TC/437 Working Group 4 on requirements and test methods for emissions from electronic cigarettes and e-liquids.
Rob Burton said “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. 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”.