Regulatory Support
Navigating the complex global regulatory landscape for pharmaceuticals and medical devices can be daunting. With extensive regulatory expertise in nonclinical requirements for therapeutics, our consultancy provides the support you need from preclinical stages through clinical development and ultimately marketing approval. Our experienced regulatory professionals partner with you to help define your regulatory strategy. We can support regulatory agency interactions and help in the preparation of briefing documents, regulatory submissions, including preparation of tabular summaries and CTD tables. We tailor our services to your specific needs, advising on strategy, minimizing regulatory risks and accelerating clinical development.
Whether you are a start-up aiming to take a novel compound into the clinic or an established company seeking to understand regulatory risks within your programs, our regulatory experts can help. In choosing our consultancy, you gain access to unparalleled industry insights that smooth your regulatory pathway and avoids unnecessary delays.
Our Regulatory Experts
David Jones
David is a European Registered Toxicologist and a Fellow of the British Toxicology Society as well as a Chartered Biologist and a Fellow of the Royal Society of Biology. David was responsible for assessing the nonclinical data for Clinical Trial Authorisation Applications and chaired over a hundred scientific advice meetings every year. His many years of experience at the MHRA provide invaluable insight to clients looking to take drugs into clinical trials.
Angela Stokes
Angela has a strong scientific background in chemistry, pharmacology and toxicology and over 30 years of regulatory affairs experience in medicinal product and medical device development. She has extensive experience of ICH, FDA and Committee for Medicinal Products for Human Use (CHMP) guidelines for a wide range of pharmaceutical products, and the International Organization for Standardization (ISO) standards for medical devices, in vitro diagnostics and quality systems. She has been influential in regulatory affairs training and mentoring and is a Fellow of The Organisation for Professionals in Regulatory Affairs (TOPRA) and a Fellow of the Royal Society of Chemistry. Angela was the winner of the 2015 TOPRA Award for Contribution and 2020 TOPRA Award for Inspiration. Angela’s knowledge, breadth of experience in regulatory affairs, toxicology and pharmacology abilities and strategic approach aligns with and supports the toxicology group in ApconiX.
