Who are we?
Sharp Regulatory Consulting Limited works with a network of trusted partner consultants and companies to ensure appropriate solutions are applied to your problems. Sharp Regulatory is managed by Angela Stokes who has worked in the pharmaceutical and medical device industry in a regulatory capacity for over 30 years.
Angela Stokes MSc CSci CChem FRSC FTOPRA
Angela is a highly motivated Regulatory Affairs and Quality professional with a strong scientific background in chemistry, pharmacology and toxicology and over 30 years of regulatory affairs and quality experience gained in both contract research organisations and pharmaceutical/medical device companies.
She is experienced in medicinal product and medical device strategy and development, quality management system setup, maintenance and training, clinical trials, registration of pharmaceuticals and medical devices, post marketing variations, line extensions and life cycle management. Angela communicates well at all levels and is an outstanding organiser and negotiator with proven team working leadership and people management skills. Throughout her career she has demonstrated an ability to work independently managing heavy workloads and meeting deadlines.
Angela has extensive experience of ICH, FDA and Committee for Medicinal Products for Human Use (CHMP) guidelines for a wide range of pharmaceutical products, and has a working knowledge of the International Organization for Standardization (ISO) standards for medical devices, in vitro diagnostics and quality systems. In the past 30 years, she has been involved in writing, quality control and reviewing vast numbers of regulatory documents for submissions around the globe. In addition, she is passionate about ensuring the next generation of regulatory and quality professionals are offered opportunities to flourish and is influential in training and mentoring. Angela has experience in a wide range of different indications and diseases from dermal fillers to dentistry, orphan diseases to oncology, and vaccines to virology. She possesses a good knowledge of the incentives available to SMEs in Europe and has helped companies take advantage of these incentives.
Angela is a Fellow of the Royal Society of Chemistry FRSC and a member of DIA. She is also a Fellow of The Organisation for Professionals in Regulatory Affairs (TOPRA) where she was on the management board for 13 years, having been President in 2018.
Angela was honoured to be shortlisted with her team for a TOPRA Award for Regulatory Excellence in the support category in 2018 and delighted to have won individual TOPRA Awards for Regulatory Excellence in 2015 in the Contribution category and in 2020 in the Inspiration category.
