CMC & Quality
Laura Millichamp is responsible for the management of projects involving the development of Chemistry Manufacturing and Controls (CMC). She provides scientific, technical and regulatory expertise and is involved in reviewing and preparing regulatory pharmaceutical documents: CMC sections of IMPD/IND, briefing packages for Scientific Advice, variations, CTD module 3, and the Quality Overall Summary of MAAs.
A UK registered Pharmacist, Laura obtained a MPharm in Pharmacy at the University of Portsmouth, and a Ph.D. in Pharmaceutical Sciences from the University of Manchester, UK in the field of hydrogels for topical drug delivery.
Laura brings 8 years of experience in the Pharmaceutical Industry, including 7 years as a Pharmaceutical Assessor at the Medicines and Healthcare Regulatory Agency (MHRA) where she assessed a broad range of active substances and finished product types including sterile, oral and topical dosage forms and Orphan Drugs. In this role Laura gained extensive experience of all licensing procedure types (Centralised, Decentralised, National, Mutual Recognition, variations, CMDh referrals, recalls). She was an EMA Expert, providing regulatory and scientific advice on a European level, and presenting challenging applications at the UK Expert committees and CHMP discussion meetings. Laura has experience of assessing MAAs including Quality by Design (QbD), Real Time Release Testing (RTRT) and Rapid Microbial Methods (RMM).
Prior to joining VCLS, Laura held the position of Senior Consultant at PAREXEL International. She provided highly successful pre and post approval regulatory strategies, authored Scientific Advice briefing packages, IMPD and dossier sections including Post Approval Change Management Protocol, prepared ATC code applications, and conducted gap analysis. Laura has experience of collaborating with companies of all sizes, from start up to global, and at all stages of the drug development process.