Regulatory Support
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.
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 written and tabular summaries and CTD tables. We tailor our services to your specific needs, advising on strategy, minimizing regulatory risks and accelerating clinical development.
Some examples of areas of support we can give:
Common Technical Document
Our experts can provide advice on the content of and authoring the:
- Nonclinical Overview Module 2.4
- Nonclinical Written and Tabulated Summaries Module 2.6
- Help you ensure that impurity control approach and documentation is consistent with ICH Q3A/B and M7, and that all relevant impurities can be shown to be qualified
Product Information
Our experts can provide advice on the safety content of product labelling in Module 1 of the Common Technical Document:
- Including those specified by regional regulatory authorities such as the United States Prescribing Information (USPI) and Summary of Product Characteristics (SmPC)
- Content may include pregnancy and contraception advice, nonclinical toxicology and boxed warnings
Pharmacovigilance
Our experts can provide a Safety Signal Assessment should there be reports of adverse effects potentially associated with a drug on the market. This assessment will evaluate the potential causality of the event, provide an expert pharmacological assessment and help advise your regulatory team what the clinical and regulatory implications might be.
- Is the signal real?
- Is the association causal?
- How serious is the risk?
- What actions, if any, should be taken?
Novel Excipients
A novel excipient as one that has not been previously used in an approved drug product, or is being used by a new route of administration or at a higher level than previously approved and therefore the excipient is not in the FDA Inactive Ingredient Database IID (for any route).
Our experts can, as part of our safety support, provide a Permitted Daily Exposure (PDE) limit.
The PDE represents a substance-specific dose that is unlikely to cause an adverse effect if an individual is exposed at or below this dose every day for a lifetime. Exposure limits are typically expressed as milligrams of substance per kg of body weight (mg/kg).
An PDE written by an ApconiX expert toxicologist will summarise decisions with justification and final numerical value, based on the most informative current toxicology data, to calculate the PDE by oral ingestion and will clearly identify any hazards known or unknown. The data and conclusions are clearly presented and data sources are referenced. As more data becomes available, the report can also be updated.
Our Regulatory Experts
Andrew Fleetwood
B.Vet.Med., C.Biol., MRSB, M.Topra, MRCVS
Andrew is a Regulatory toxicologist, and has had a long career in industry supporting the registration of new products through the FDA and EMA and Rest of World processes. This has included the management of a regulatory toxicology group, and Andrew is now acting as a consultant. Andrew manages the preparation of the nonclinical file for regulatory applications (The Common technical Document Modules 2.4 and 2.6); authoring of the safety sections of labelling (USPI and SmPC); responses to regulatory questions; and safety signal assessment for pharmacovigilance.
Jo Threlkeld
Jo brings over 35 years of pharmaceutical industry experience in regulatory strategy and development leadership, over 30 years in large pharmaceutical companies. She has successfully navigated complex regulatory pathways across multiple therapy areas including oncology, infectious diseases, and cardiovascular medicine, with particular expertise in anti-infective development and early clinical development strategy.
Throughout her career, Jo has led regulatory strategy and submissions for a wide range of programmes, most recently, she has achieved two successful EU Marketing Authorisation Applications for new antibiotics. Jo serves on a Scientific Advisory Board, where she provides regulatory and strategic insight to guide portfolio optimisation and development decisions.
David Jones
MSc, EurBiol, CBiol, FRSB, ERT, FBTS
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
MSc CSci CChem FRSC FTOPRA
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.
