Sharp Regulatory Consultancy Limited is ready to serve clients looking for an independent regulatory affairs consultancy having the backing of a large network of specialists in areas such as toxicology, real world evidence, publishing etc.
When Angela became a regulatory affairs officer over thirty years ago the profession of regulatory affairs was in its infancy. Today, it has become a major part of product development emerging from a need to protect public health by controlling the safety, efficacy and performance of products in areas including pharmaceuticals and medical devices. Governments and companies responsible for the discovery, testing, manufacture and marketing of such products all have an obligation to ensure that the products they supply are safe and contribute to public health.
Having learned her trade for more than thirty years, Angela has decided to branch out on her own and provide the benefit of her experience as a consultant to the industry and academia. Her extensive experience of ICH, FDA and Committee for Medicinal Products for Human Use (CHMP) guidelines for a wide range of pharmaceutical products, and understanding of the International Organization for Standardization (ISO) standards for medical devices, in vitro diagnostics and quality systems will help her to provide a first class service to clients. Professionally, Angela is a Fellow of The Organisation for Professionals in Regulatory Affairs, a Fellow of the Royal Society of Chemistry, winner of the 2015 TOPRA Award for Contribution and 2020 TOPRA Award for Inspiration.