Our consultants are experts in a number of specialist fields. Their knowledge allows expert scientific consideration of issues in these areas and they have the experience of putting that science into regulatory context.

Of course, we understand that some clients prefer a single solution for all aspects of risk assessment, dossier preparation and study monitoring. Consequently, we have brought together Associate Consultants with a range of complementary skills gained over many years working in R&D industries, CROs and consulting companies. These recognised experts deliver the highest quality output with a single project management and administrative focus, providing intelligent, effective, high quality and forward-looking scientific and regulatory solutions to meet your business needs.

Whether you need a single solution for risk assessment, specialist toxicology support or advice from highly experienced regulatory affairs specialists, RSA. provides effective regulatory science solutions.

AllAdvocacyAnalytical ChemistryBusiness and Financial administrationDossier ComplianceEndocrine DisruptionEnvironment ToxicologyEnvironmental FateGenetic ToxicologyInformation TechnologyInhalation ToxicologyMechanistic ToxicologyMetabolism and KineticsNeurotoxicologyOncogenicityOperator ExposurePathologyProject ManagementRegulatory AffairsRegulatory ToxicologyReprotoxicologyRisk AssessmentSafety PharmacologySARStudy Monitoring
AllAg ChemChemicalsPharmaceuticals
RSA Mary Moxon

Mary Moxon BSc MSc

Consultant Toxicologist

Ag Chem -Chemicals -Dossier Compliance -Endocrine Disruption -Pharmaceuticals -Regulatory Toxicology -Reprotoxicology -Study Monitoring

RSA Mary Moxon

Mary Moxon BSc MSc

Consultant Toxicologist

Mary commenced her career in reproductive toxicology at Huntingdon Research Centre in 1975. She joined the Central Toxicology Laboratory at ICI in 1981, as a Study Director for developmental toxicity and reproduction studies and Work Group Leader of the foetal pathology unit. Over the years, Mary became a Study Director for a wide range of toxicological studies using different species and various routes of administration whilst retaining her expertise in reproductive toxicology. With the formation of Syngenta and the addition of the contract research business to CTL, Mary became the technical lead for external clients, including Pharma, requiring reproduction studies, and has become experienced in designing and conducting complex studies for specific programmes of work.

Mary has extensive experience of mammalian reproductive and developmental toxicology including Study Monitoring and management, data evaluation and interpretation, regulatory report compilation and rebuttal preparation. On the basis of this expertise, she has been appointed to the Scientific Advisory Panel of a leading CRO. In addition, Mary is actively involved in the review of existing information on chemicals to fulfil the requirements of REACH, the review of data to identify substances with endocrine disruption potential and the preparation of position statements to support the registration of agrochemical and chemical substances.

RSA Paula Batten

Paula Batten BSc PGD

Regulatory Affairs Manager

Advocacy -Ag Chem -Chemicals -Project Management -Regulatory Affairs

RSA Paula Batten

Paula Batten BSc PGD

Regulatory Affairs Manager

Paula has over 20 years’ experience working in the agrochemical industry (ICI, Zeneca, Syngenta) firstly as a research plant biologist at Jealott’s Hill Research Station before moving into product registration. For the last 13 years Paula has worked opposite the EU and member states as a Regulatory Project Manager delivering active substance and plant protection product dossiers for EU and national registration/re-registration, and managing all aspects of the dossier review with the regulatory agency. Paula has an in-depth and current knowledge of the regulatory processes operated by Rapporteur Member States, the European Food Safety Authority and the EU Commission when reviewing new and existing active substances in accordance with Directive 91/414/EEC. In addition Paula has followed the development of new legislation and is well placed to advise on the technical and process changes associated with the introduction of Regulation (EC) No 1107/2009.

RSA Richard Murray-Smith

Richard Murray-Smith BSc

Consultant, Environmental Risk Assessment

Advocacy -Ag Chem -Chemicals -Environment Toxicology -Environmental Fate -Pharmaceuticals -Project Management -Risk Assessment

RSA Richard Murray-Smith

Richard Murray-Smith BSc

Consultant, Environmental Risk Assessment

Richard has over 20 yrs experience and is an internationally acknowledged Environmental Risk Assessment (ERA) expert specialising in pharmaceuticals and general chemicals. Previously Head of Global ERA at AstraZeneca, Brixham until he joined RSA in 2016, Richard has the ability to lead multi-functional teams and >30 major client projects while at AstraZeneca.

Richard is a highly customer-focused and experienced Project Manager with a proven track record of delivering quality outputs to meet client and regulatory needs. Richard has a highly analytical, ‘fit for purpose’ mind-set and clear presentation and writing skills.

Richard has extensive experience with small molecules in the oncology therapeutic area. Oncology drugs often have several characteristics which require special consideration with respect to environment (highly potent, often cytotoxic, endocrine active etc.).

RSA Sandra Allen

Sandra Allen BSc PhD CBiol MRSB

Consultant Toxicologist

Advocacy -Ag Chem -Chemicals -Neurotoxicology -Pharmaceuticals -Project Management -Regulatory Toxicology -Safety Pharmacology

RSA Sandra Allen

Sandra Allen BSc PhD CBiol MRSB

Consultant Toxicologist

Sandra has a first degree in Pharmacology, a PhD in Experimental Neurology and 24 years’ experience as an industrial toxicologist at ICI/Zeneca/Syngenta Central Toxicology Laboratory (CTL). Sandra had a number of roles at CTL and was finally Head of Regulatory Toxicology. Sandra has an international reputation as an expert in neurotoxicology and is regularly invited to speak on this topic (most recently at a 1 day course for ECHA). She has extensive expertise in the design, conduct and interpretation of a full range of toxicology studies ranging from acute to lifetime exposures in a variety of species, including method development, novel research and human volunteer studies.

Sandra’s expertise covers industrial chemicals, agrochemicals and pharmaceuticals (including biologicals) and she has designed and project managed the delivery of testing programmes which meet all aspects of safety, efficacy and regulatory requirements as needed for product development. She now provides technical consultancy and advice to a variety of clients in a wide range of business sectors.

Mac Provan BSc PhD

Director

Advocacy -Ag Chem -Analytical Chemistry -Chemicals -Mechanistic Toxicology -Metabolism and Kinetics -Oncogenicity -Project Management -Regulatory Toxicology -Risk Assessment

Mac Provan BSc PhD

Director

Mac has over 30 years’ experience in chemistry, biochemistry and toxicology with major companies (ICI, Zeneca and Syngenta) and was an investigative toxicologist at the world-famous Central Toxicology Laboratory (CTL) from 1979 to 2003. He is a recognised expert in the investigation and understanding of the role of metabolism and kinetics in species-specific responses to xenobiotics and has made numerous contributions in this field of regulatory science.

In addition to these key scientific skills, Mac also has significant experience of project management and information systems management. He was responsible for development of appropriate in-house ‘decision-making’ safety information for potential new products, prior to defining and managing the development of safety data packages and science-based registration strategy for new product registration and/or defence. More recently Mac has been involved in REACh technical dossier compilation and project management, particularly for substances with complex toxicology issues.

Dave Berry BSc

Regulatory Consultant Toxicologist

Advocacy -Ag Chem -Chemicals -Operator Exposure -Project Management -Regulatory Toxicology

Dave Berry BSc

Regulatory Consultant Toxicologist

Dave is an experienced regulatory consultant toxicologist with over 35 years of experience with leading chemical and agrochemical companies. He also has had wide general regulatory experience with a particular focus on Japan, South Korea and the USA and has extensive project management experience in the agrochemical and biocides markets. Dave has also project managed 2 human investigative studies in Asia and was responsible for managing a global alert system for monitoring of adverse health effects from pesticide exposures. Dave has a first degree in Applied Biology and a post-grad certificate in Medical Toxicology from Cardiff University.

RSA David Lees

David Lees BSc (Hons), IDT, ERT

Consultant Toxicologist

Ag Chem -Chemicals -Dossier Compliance -Genetic Toxicology -Inhalation Toxicology -Pharmaceuticals -Regulatory Toxicology -Study Monitoring

RSA David Lees

David Lees BSc (Hons), IDT, ERT

Consultant Toxicologist

David is a European Registered Toxicologist with over 30 years experience in the design, conduct, interpretation and reporting of complex toxicology studies and in preparation of high level summaries and submission documents.  He has led teams as an expert toxicologist for global companies across the agrochemical, industrial chemical and pharmaceutical industry sectors.

David started his career at the ICI/Zeneca/Syngenta Central Toxicology Laboratory (CTL) at Alderley Park and became a senior multidisciplinary Study Director/Study Monitor and Project Licence Holder with responsibility for toxicology studies ranging from acute to lifetime exposures in the full range of species and dose routes.  David joined AstraZeneca Pharmaceuticals in 2007 (Regulatory Safety Group) and has extensive experience in the safety assessment of pharmaceuticals.  More recently he has specialised in outsourcing and monitoring nonclinical toxicology studies.  He has designed and monitored drug development studies ranging from dose range finding (DRF) to pivotal toxicology studies for a wide range of therapy areas and for both small molecules and new drug modalities.

Alex McCormick BSc PhD

Consultant, Drug Metabolism and Pharmacokinetics

Ag Chem -Analytical Chemistry -Chemicals -Metabolism and Kinetics -Pharmaceuticals

Alex McCormick BSc PhD

Consultant, Drug Metabolism and Pharmacokinetics

Alex started his career at ICI/Zeneca/AstraZeneca initially as an in vitro metabolism Study Director, progressing through senior SD and Team leader roles in DMPK to become Associate Director of DMPK in 2005, and then Senior Project Leader for DMPK and Clinical Pharmacology until he left AstraZeneca in 2016 to join RSA. Alex has a proven record of effectively delivering DMPK studies, regulatory packages and regulatory documentation for novel pharmaceuticals, from compound nomination to post marketing commitment.

In his senior roles, Alex was responsible for managing risks, resources and project budgets within his department. Alex’s responsibilities included leading all aspects of preclinical and clinical DMPK activities for small molecule oncology and infection projects from lead optimisation to life cycle management, co-ordinating expert development of preclinical pharmacokinetic/pharmacodynamic models for prediction of human pharmacokinetics and therapeutic dose, preparing clinical pharmacology plans and support delivery of clinical pharmacokinetics, and preparing functional contributions to higher level summaries and regulatory dossiers at all stages of drug development, attending regulatory interactions as required.

Gary Roberts BSc PhD

Consultant, Environmental Fate and Risk assessment

Advocacy -Ag Chem -Analytical Chemistry -Chemicals -Environment Toxicology -Environmental Fate -Metabolism and Kinetics -Pharmaceuticals -Project Management -Risk Assessment -SAR

Gary Roberts BSc PhD

Consultant, Environmental Fate and Risk assessment

Gary is a skilled environmental fate specialist and risk assessor, having formed part of the scientific team at Brixham Environmental Laboratory (BEL) between 1985 and 2014 (ICI, Zeneca and then AstraZeneca). His broad experience encompasses a range of chemical industry sectors, including biocides, pesticides, industrial chemicals and pharmaceuticals.

Gary has experience of the use of QSAR models as a screening tool for selection of “greener” molecules. Since the introduction of environmental risk assessment for pharmaceutical ingredients in 2006, Gary has focused on the risk assessment of pharmaceuticals, developing novel approaches for tests, whilst satisfying international regulatory guidelines.

Gary has served on European scientific committees including the EU Biocidal Products Directive Notes for Technical Guidance, working with several large biocide companies to support them with compliance with the directive. Gary also chaired an ECETOC (European Centre for Ecotoxicology and Toxicology of Chemicals) Task Force, which developed interim guidance for the inclusion of Non-extractable Residues (NER) in environmental risk assessment.

He is currently a member of the ECETOC monitoring team overseeing the CEFIC (The European Chemical Industry Council) LRi (Long-range Research initiative) research project ECO 24, which aims to improve the prediction of NER formation using structural alerts and QSARs.  Gary is also a member of the ECETOC monitoring team for ECO 25, which oversees a research project focused on the development of ecotoxicity tests for assessing the environmental risk of NER in soil.

RSA Jeanette Barber

Jeanette Barber (HNC (Applied Science), Licensee of the Institute of Biology – Pharmacology)

Director, Regulatory Affairs

Ag Chem -Chemicals -Dossier Compliance

RSA Jeanette Barber

Jeanette Barber (HNC (Applied Science), Licensee of the Institute of Biology – Pharmacology)

Director, Regulatory Affairs

Jeanette has over 30 years’ experience in toxicology. She commenced her career with ICI Pharmaceuticals in 1976. She then worked in the world renowned Central Toxicology Laboratory (part of ICI, Zeneca and latterly Syngenta). Her expertise includes the ability to abstract, collate, interpret and summarise data from mammalian and eco-toxicology studies and to present it in a format that meets the requirements of international submission dossiers for submission to regulatory authorities. (e.g. for OECD and REACH IUCLID 5 dossiers).

Jeanette is experienced in drafting summaries of endocrine effects from mammalian and eco-toxicology studies. She also reviews data to provide the basis for rebuttal statements, preparation of competitor reviews and auditing of studies for compliance with GLP. She has worked for clients in chemical, agrochemical and pharmaceutical industries and consortia.

RSA Mike Allen

Mike Allen

Information Technology Management

Information Technology

RSA Mike Allen

Mike Allen

Information Technology Management

Mike has over 30 years’ experience of all aspects of IT, working for a variety of companies including Digital Equipment, Compaq, Ferranti, Thorn EMI, Renolds Westinghouse Brake and Signal, and Barclays. He has worked in many areas such as finance, warehousing, engineering, telecommunications, process control, utilities, chemicals, commercial, tobacco, health services, health and safety, transport, education and all aspects of systems management.

Mike supports RSA in maintenance and repair of hardware, software recommendation and testing, liaising with external suppliers, writing user documentation, training users in new systems and maintaining the intranet sites.

RSA Alison Brammer

Alison Brammer BSc MSc

Consultant Toxicologist/Study Reviewer

Ag Chem -Chemicals -Dossier Compliance -Pharmaceuticals -Regulatory Toxicology -Safety Pharmacology -Study Monitoring

RSA Alison Brammer

Alison Brammer BSc MSc

Consultant Toxicologist/Study Reviewer

Alison has extensive practical experience of mammalian toxicology studies from a career with ICI Pharmaceuticals Division and the Central Toxicology Laboratory (latterly Syngenta) from 1982 until 2008. She was a highly experienced multi-disciplinary Study Director with a wide range of experience in the design, conduct, interpretation and reporting of a range of toxicology and safety pharmacology studies for both Syngenta and external clients.

During her career with ICI, Alison gained an Honours degree in Applied Biology. She then gained a post-graduate Diploma of the London School of Hygiene and Tropical Medicine and a Masters in Clinical Trials in 2013.

Since joining RSA, Alison has preparedREACH IUCLID robust summaries and endpoint summaries She is a Study Monitor working with a number of contract laboratories to deliver a range of Regulatory toxicology and environmental toxicology tests for clients. She is skilled in interpreting data, presenting facts clearly and in the liaison between the Laboratory and client.

RSA Alison McCondichie

Alison McCondichie MA

Financial and Business Administrator

Business and Financial administration

RSA Alison McCondichie

Alison McCondichie MA

Financial and Business Administrator

After graduating in Archaeology and History from the University of Glasgow in 2004, Alison initially worked in commercial field-work investigations before taking on her first business administration role within a local yachting business. She has a long association with Directors Mac and Charlotte, having worked with them on other projects, and acts as the “hub” of the RSA business. Alison is also the main point of contact for any financial/administrative queries, and acts as Information Manager on literature searches.

RSA Barry Elliott

Barry Elliott BSc MSc PhD

Consultant Toxicologist

Advocacy -Ag Chem -Chemicals -Genetic Toxicology -Mechanistic Toxicology -Oncogenicity -Pharmaceuticals -Regulatory Toxicology -Risk Assessment -SAR

RSA Barry Elliott

Barry Elliott BSc MSc PhD

Consultant Toxicologist

Barry has more than 30 years of experience in toxicology ranging from investigative toxicology to project management. His core discipline spanning this time has been genetic toxicology and Barry is a recognised expert in this field, with membership of expert Committees and also past appointments as President of the UKEMS and Secretary of the EEMS. He has an interest and expertise in chemical structure activity relationships in genetic toxicology and carcinogenesis. He joined ICI following his PhD and has held positions with this company and through subsequent mergers to the current Syngenta, including Head of Genetic Toxicology, Head of Metabolism and Genetic Toxicology and Senior Toxicologist responsible for all toxicology areas of a portfolio of leading agrochemical products. Barry has prepared and presented positions on chemicals to regulatory agencies around the world. During his time in ICI and also latterly in Syngenta through its contract research business, Barry has been involved with chemicals in the Industrial, Pharmaceutical and Agrochemical sectors.

RSA Gill Milburn

Gill Milburn BSc

Consultant Toxicologist

Ag Chem -Chemicals -Pharmaceuticals -Regulatory Toxicology -Reprotoxicology -Study Monitoring

RSA Gill Milburn

Gill Milburn BSc

Consultant Toxicologist

Gill started her toxicology career with ICI/Zeneca/Syngenta Central Toxicology Laboratory (CTL) in 1976 working in inhalation toxicology. In 1981 she moved to the reproduction and long term area to manage studies and technical staff. She has acted as a Study Reviewer, Study Director, Facility Manager, and Study Monitor in the regulatory toxicology area advising on the design, conduct and interpretation of a diverse range of mammalian toxicology studies for both Syngenta and external clients. Her work has included regulatory and research studies on agrochemicals, industrial chemicals, pharmaceuticals, medical devices and food stuffs. She has mentored and trained Study Directors and Study Monitors. Gill has an interest in animal welfare and has been a Project Licence holder and Syngenta representative on NC3Rs/LASA Safety Evaluation Working Group. She was also a member of an ECETOC Task Force reviewing and providing expert comments on the original draft OECD reproductive screening protocols (OECD 421 and 422). Since joining RSA Gill has worked on REACH, CLH and endocrine disruption projects and as a Study Monitor. (She has also produced biological evaluation reports for Medical Devices.)

RSA Jenny Odum

Jenny Odum BSc MSc PhD

Consultant Toxicologist

Advocacy -Ag Chem -Chemicals -Endocrine Disruption -Mechanistic Toxicology -Pharmaceuticals -Project Management -Regulatory Toxicology -Reprotoxicology

RSA Jenny Odum

Jenny Odum BSc MSc PhD

Consultant Toxicologist

Jenny has 25 years’ experience in toxicology, working for ICI, Zeneca and Syngenta. She has a broad range of expertise within toxicological specialities and has published widely. She is an expert in the field of endocrine disruption and is a member of a number of OECD expert panels on testing for endocrine disruption. She has provided specialist advice on endocrine disruption and written position statements for compound defence.

Jenny has skills in investigative toxicology, regulatory toxicology and project management. She has been responsible for the scientific and technical integrity, design, conduct and interpretation of a wide range of studies for clients involving industrial, agrochemical and pharmaceutical chemicals. She has also led the preparation of REACH dossiers and population of IUCLID 5.

RSA John Foster

Professor John Foster PhD, DipRCPath, FRCPath, Hon FBTS, FIATP

Principle Consultant Pathologist

Advocacy -Ag Chem -Chemicals -Mechanistic Toxicology -Oncogenicity -Pathology -Pharmaceuticals

RSA John Foster

Professor John Foster PhD, DipRCPath, FRCPath, Hon FBTS, FIATP

Principle Consultant Pathologist

John obtained his first degree in Zoology from the University of Wales in 1975 before undertaking research, on liver pathology, for which he was awarded a PhD in 1978. He then joined the British Industrial Biological Research Association (BIBRA), at Carshalton in the UK, as an experimental pathologist and head of the electron microscopy unit, which he left in 1983 to join the Pathology Department of ICI Central Toxicology Laboratory in Cheshire, United Kingdom. He became a member of the UK Royal College of Pathologists in 1988, was elected a Fellow in 1997, and ran the Specialty Advisory Committee for Toxicology from 2002-2005. He was Chair of the Panel of Examiners for the Toxicology Specialty of the RCPath from 2006-2012 and remains an examiner for the College.

He was a science-reviewing member of ECETOC’s LRI on Carcinogenicity from 2000-2006 and he sat on the UK Food Standard Agency’s Committee on Toxicity from 2006-2012. He was President of the British Society of Toxicological Pathologists from 2002-2004. He was appointed an Honorary Fellow of the British Society of Toxicology in 2008, was made an Emeritus Professor in the Faculty of Health and Medical Sciences at University of Surrey in 2010 and was elected as an Honorary Fellow of the BSTP in the same year. In 2011 he was made an Honorary Fellow of the Latin American Society of Toxicologic Pathologists and became a Fellow of the International Academy of Toxicologic Pathology in September of 2012.

Prof Foster has published over 130 research papers, review articles and book chapters in toxicological pathology, and was the Editor in Chief of the journal, Toxicologic Pathology from 2008-2013.

He worked for AstraZeneca Pharmaceuticals from 2001 until the end of 2013 as a Senior Principal Pathologist and Deputy Director of Pathology, joining RSA in January 2014.

RSA Jo Kilgour

Jo Kilgour BSc MSc PhD ERT

Consultant Toxicologist

Advocacy -Ag Chem -Chemicals -Dossier Compliance -Inhalation Toxicology -Mechanistic Toxicology -Pharmaceuticals -Project Management -Regulatory Toxicology -Study Monitoring

RSA Jo Kilgour

Jo Kilgour BSc MSc PhD ERT

Consultant Toxicologist

Jo has over 20 years experience in industry and is a recognised expert in specialist field of inhalation toxicology. Jo is a skilled toxicologist whose early experience as Study Director/Study Monitor formed a strong foundation from which to move into toxicology project management. Initially Jo worked as a Project Toxicologist in the agrochemicals/chemicals sectors with Zeneca/Syngenta. More recently, she has worked in the pharmaceutical sector, where she has spent the last 8 years at AstraZeneca focusing on inhaled drug development for a number of respiratory diseases including COPD, Asthma and Cystic Fibrosis.

Her experience covers all aspects of toxicology program design and conduct in drug development from DRF studies and pivotal toxicology studies for FTIM submissions, to life cycle management of registered products. Jo has successfully completed many regulatory submissions (new product and re-registrations) in both sectors, involving regulatory authority interactions and defence in many territories including the EU and US (EPA/FDA).

Jo maintains a respected external profile through her work on various committees, which include holding the current Chair of the Association of Inhalation Toxicologists (AIT). Jo has previously chaired the Education Sub-Committee of the British Toxicology Society (BTS) and has played a pivotal role in a number of external initiatives including the APSGB-HESI emerging issues workshop (and subsequent publication) on alveolar macrophages in inhaled drug development, and the current NC3Rs “Crack-It” Challenge on Inhalation Translation.

RSA Judy Knight

Judy Knight BSc (Hons)

Regulatory Affairs Manager

Advocacy -Ag Chem -Chemicals -Project Management -Regulatory Affairs

RSA Judy Knight

Judy Knight BSc (Hons)

Regulatory Affairs Manager

Judy has over 25 years’ experience in the agrochemical industry (ICI, Zeneca and Syngenta) mostly in Regulatory Affairs as a European Project Manager, and including a 6-month secondment to the biocides regulatory team. Latterly, she has worked for a contract company providing pharmaceutical regulatory services on contract. She has a strong technical background with early experience as a technician in a university research and teaching unit for tropical diseases, and with ICI / Zeneca; in field trials, lead discovery, and entomology. She is skilled in writing and explaining scientific findings simply, and in liaison between regulators and scientists.