Regulatory Consultants in Europe

Bernalyn McGaughey
President / CEO

In addition to providing corporate oversight for CSI’s various regulatory and scientific teams, Ms. McGaughey’s extensive industry background can be drawn upon to address key project issues across the company. Bernalyn has over 40 years of data evaluation, chemical research, study monitoring, and project management experience in the properties, use, toxicology, and environmental fate of pesticides and other chemicals. Her activities have included original and regulatory research, report design and composition, and international technical assistance on toxicology investigations and risk assessments. She is a recognized scientific expert witness, industry task force manager, and strategist on pesticide risk and issue analysis.  She has done extensive work in endangered species assessment and issue analysis with respect to the intersection of the Endangered Species Act and other statutes.

Prior to founding CSI in 1988, Bernalyn held various regulatory and technical positions with Pennwalt and Shell Chemical Corporation’s agricultural chemical divisions. She has extensive pesticide regulatory and industry knowledge. She currently administers the FIFRA Endangered Species Task Force of agrochemical producers.

Frank Galloway BA MTOPRA CBiol MRSB
Senior Science Fellow

Frank has regulatory, commercial & research experience spanning over 30 years. He has worked extensively with consortia and task forces supporting crop protection & biocidal product active substances and industrial chemicals. Several active substances on which Frank worked have been positively listed in the Annex to Regulation No. 540/2011 implementing the Plant Protection Product Regulation No. 1107/2009 as regards the list of approved active substances. Additionally several active substances on which Frank worked have been positively listed under the Biocidal Product Regulation No. 528/2012. Frank has also provided management oversight on multiple REACH registration projects.

Frank’s industry experience was gained with Shell Research while screening novel organic compounds for plant growth regulatory activity. As a past regulator with the former UK Pesticides Safety Directorate (now part of the Chemicals Regulation Directorate of the Health and Safety Executive), Frank conducted operator, consumer and environmental risk assessments for agricultural pesticides and prepared recommendations for consideration by government departments. Frank expanded his regulatory experience internationally and to include a wide range of chemical sectors while working for the former contract research organisation Inveresk Research (now part of Charles River Laboratories). His commercial experience was gained while working as a business analyst for Wood Mackenzie, a division of several investment banks including latterly Deutsche Bank. Frank’s work has included assessment of the economic impact of regulatory legislation on behalf of a crop protection industry trade association, as well as the conduct of regulatory due diligence in support of merger and acquisition advisory projects.

Shirley Hudson BSc CBiol MRSB
Senior Science Fellow

Shirley is an experienced mammalian toxicologist, specializing in human health assessment. Her career of more than 25 years has included senior positions with leading contract research and consulting organizations where she has focused on regulatory compliance of toxicology studies, data gap analysis, and quality checks of toxicological data packages. Shirley also has extensive Study Director experience in developing and directing mammalian toxicology studies in a Good Laboratory Practice (GLP) compliant working environment, in support of registration of agrochemicals, biocides, human health products, and industrial chemicals. Shirley has been lead author and peer reviewer of scientific reports for submission to international regulatory authorities and was a co-author of ‘Guidance on dose level selection for regulatory general toxicology studies for pharmaceuticals’ published by the National Centre for the Replacement, Refinement and Reduction of Animals in Research (NC3Rs) and the Laboratory Animal Science Association (LASA). She has liaised with regulatory authorities and participated in industry task forces. She is a chartered member of the Society of Biology and a member of the British Toxicology Society.

For CSI clients, Shirley prepares registration dossiers and risk assessments and provides expert toxicological support for plant protection products, chemicals, biocides, animal health products, cosmetic products and food contact materials. Shirley has successfully prepared and submitted REACH substance and intermediate dossiers for the November 2010 and May 2013 deadlines.

Warren Scott BSc (Hons)
Principal Business Development Consultant

Warren has over 25 years experience in laboratory contract research studies and business development for contract research organizations. His experience encompasses projects in various business sectors including agrochemical, chemical, veterinary, and biocidal products. Warren qualified as a Soil Scientist and prior to joining CSI held scientific and business development positions at Inveresk Research and Wildlife International. His work at these firms included the coordination of study programmes and the preparation/submission of study documents to support product registrations. His scientific background focused on environmental fate chemistry, where he developed testing strategies for EU-regulated products and conducted laboratory environmental fate studies.

At CSI Warren conducts a dual role – sharing consulting activities with a business development remit. He serves as CSI’s REACH Program Coordinator and has accumulated considerable REACH experience fronting CSI’s activities as an Only Representative, Third Party Representative and Consortium Secretariat.

Anna Rowbotham BSc (Hons) PhD
Principal Consultant

Anna has over 25 years of experience in toxicology, exposure modelling and human health risk assessment gained in senior scientific and management positions in consultancy, regulatory, industry and research settings. Prior to joining CSI, Anna led a multi-disciplined team of specialists at a regulatory consultancy to deliver high quality technical and scientific services and advice to clients in the agrochemical, biocide and industrial and specialty chemicals industries. Anna has broad regulatory experience including: dossier preparation, the provision of high level and strategic advice, preparation of expert statements, classification and labelling, testing strategies and read-across and human exposure modelling using standard and bespoke models.

In a previous role at the Health and Safety Laboratory, Anna led a programme of technical support for the UK Chemicals Regulation Directorate (CRD) for biocides and industrial chemicals and conducted research to develop probabilistic population-based computational toxicokinetic models. She was involved in chemical safety work as part of the Government Chemist Programme while at LGC Ltd., and conducted consumer dietary risk assessments for the registration of crop protection products while at Syngenta. Anna has authored high quality critical reviews on contemporary chemical risk assessment issues for the MRC Institute for Environment and Health, as well as other publications and has provided training across various human health risk assessment topics. Anna has a degree in Biochemistry and a PhD in Neurotoxicology and is a member of the British Toxicology Society.

At CSI, Anna prepares registration dossiers and risk assessments and provides toxicological support for plant protection products, chemicals, biocides, animal health products, cosmetic products and food contact materials.

Robin Blake BSc (Hons) PhD PMP CSci FRSB
Principal Consultant

Robin has a BSc (Hons) in Applied Biology from the University of Bath, and a PhD in Agricultural Ecology from the University of Reading. The topic of his thesis was to investigate management methods to enhance biodiversity in non-cropped grass buffer strips for the benefit of flora and fauna including bees, butterflies and spiders. He has spent over 12 years working within R&D in the agrochemical industry for both Cyanamid Agriculture UK and Syngenta, and has experience in several broad areas including field trials, entomology, pesticide resistance, and herbicide research. Robin has extensive experience working as a Study Director in a Good Laboratory Practice (GLP) compliant environment within the ecotoxicology department at Syngenta. Within this role, Robin specialised in terrestrial ecotoxicology and conducted laboratory, semi-field and field trials on a range of non-target arthropods, earthworms, honeybees and non-target plants, as well as conducting regulatory risk assessments for the support of plant protection products. Robin is a Chartered Scientist (CSci), Fellow of the Royal Society of Biology (FRSB), Chair for the Agrisciences technical interest group of the Society of Chemical Industry (SCI), and holds the Project Management Professional (PMP) accreditation.  In addition, he is Associate Editor for the journals Pest Management Science and Outlooks on Pest Management.

At CSI, Robin prepares registration dossiers and risk assessments for plant protection products and biocides, and provides support for industrial chemicals, pharma and cosmetic products, and food contact materials.

Siân Roberts BSc
Senior Consultant

Siân is a chemistry graduate with over 10 years’ experience in a Good Laboratory Practice (GLP) compliant working environment. Siân has extensive contract research experience as a Study Director in both analytical chemistry and animal health product development areas. Sian’s experience includes providing analytical support for a diverse range of regulatory studies, comprising of field residue trials and environmental fate studies. Siân has also been involved in the conduct of residue depletion studies in various common livestock species. Siân’s experience of analytical techniques includes GC, GC-MS, HPLC, LC-MS and LC-MS/MS. Siân also has experience of working in the Good Clinical Practice (GCP) environment, as a clinical trial project coordinator. Her role included the coordination of trials and the preparation and subsequent submission to regulatory authorities of study documents.

At CSI, Siân prepares registration dossiers and risk assessments, as well as provides support for plant protection products, biocides, chemicals, pharma products, cosmetic products and food contact materials.

Steven Andrews BSc (Hons)
Senior Consultant

Steven has a BSc (Hons) in Chemistry with Management from the University of Edinburgh. After graduating he worked in a quality control laboratory performing Environmental Safety testing and supporting lot release for active ingredients and isolated intermediates. Steven has extensive experience within contract research organizations, working as a Study Director in a Good Laboratory Practice (GLP) compliant environment within the Environmental Sciences department of Charles River Laboratories and has experience of Good Clinical Practice (GCP) within the Laboratory Data Management department at Quintiles. Within the Study Director role, Steven specialised in Environmental Fate and conducted laboratory studies in a range of environmental matrices and conditions on a range of compounds including agrochemicals, human pharmaceuticals and veterinary products, before conducting data management in his clinical trials role for studies in various therapeutic areas ranging in complexity and scale from 20 to >10,000 patients. Steven is a certified Lean Six Sigma Greenbelt, providing for a methodology whereby waste and variation are systematically removed from a process to improve performance.

At CSI, Steven provides regulatory support of biocides, chemicals, and plant protection products with a focus on environmental risk assessment and analytical methods.

Lorna Phillips BSc (Hons)
Senior Consultant

Lorna is a Life Sciences graduate with over 15 years’ experience in a Good Laboratory Practice (GLP) compliant working environment. Lorna has extensive contract research experience as both a scientist/Study Director in the Environmental Fate and Metabolism department at Charles River Laboratories (CRL) and as a QA auditor, also at CRL, providing QA support and advice to the Field Trials, Animal Health Product Development, Environmental Fate and Metabolism and Chemistry departments. Lorna has worked as a consultant at CSI for 9 years with experience in dossier preparation for biocides, plant protection products and chemicals.

At CSI, Lorna currently prepares biocides registration dossiers and assists with environmental risk assessments for chemicals and biocides. Lorna also provides additional support for plant protection products, biocides and chemicals.

Nick Keeble BSc (Hons) MRSC

Nick graduated from Heriot-Watt University with a BSc (Hons) in Chemistry. He spent ca. 5 years working for Charles River Laboratories in a Good Laboratory Practice (GLP) environment, and was a Study Director in the Environmental Fate and Metabolism department. Within this role, Nick managed bio-transformation/metabolite profiling studies involving human pharmaceuticals, agrochemicals, veterinary products and chemicals. Nick also specialised in designing photolysis and hydrolysis studies for complex active ingredients whilst working within OECD chemical testing guidelines.

At CSI, Nick prepares dossiers for Biocidal Products and Plant Protection Products specialising in Analytical Methods and Environmental Risk Assessments.  He also provides regulatory support for REACH, Food Contact Materials and Cosmetic areas.

Sarah Horgan MSc
Associate Consultant

Sarah is a Biochemistry graduate with an MSc in Toxicology. Her background includes research on mammalian reproductive and genetic toxicology. Sarah has experience as a trainee Study Director within the Toxicology department of a leading CRO, supporting both study set-up and study management for the General toxicology and Reproductive toxicology teams in a Good Laboratory Practice (GLP) environment. Such studies supported the registration of agrochemicals and pharmaceuticals. Sarah has experience with protocol production and study design, ensuring compliance with GLP through the in-life stage, data compilation and statistical analysis, report writing, data interpretation and quality control of both data and reports.

At CSI, Sarah prepares registration dossiers and risk assessments for biocides, chemicals, cosmetic products, food contact materials and plant protection products.