TSG - Key Persons
Amanda Phelka has over 20 years' experience assessing human health risk from occupational and environmental chemical exposure. An experienced toxicologist, Amanda supports the science team.
Amanda specializes in supporting the registration of pesticides, providing a scientific perspective to FIFRA registrations. She is also experienced in Proposition 65 exposure assessments and preparing submissions for Food Contact Notifications.
Amanda has previously served as a department director of a diverse team of toxicologists, a technical expert supporting toxic tort litigation efforts, and a human health risk assessor specializing in direct and indirect drinking water additives.
Amanda has a PhD and MS in Toxicology from the University of Michigan, Ann Arbor and a BA in Biology and Chemistry from Adrian College.
April Kitchen specializes in US state pesticide registration and renewals process with a focus in the Agrochemical Industry. April also has substantial experience working with state regulatory authorities, including California's Department of Pesticide Regulation.
In addition to routine state pesticide filings, April has experience registering pesticides with complex data submissions, handling 24c's and 2(ee)'s, and resolving efficacy and label issues. Her industry experience allows her to develop regulatory strategies that take into consideration the commercial goals of our clients, especially in the areas of 50 state discontinuance strategies and company name changes. She is also well-versed in the state-level registration of new active ingredients.
Job Titles:
- a Regulatory Specialist
- Regulatory Specialist
Darlene joined TSG as a Regulatory Specialist where she will support the registration and renewals team. Prior to joining TSG, Darlene focused on exploring the interaction of nutrition and exercise on health and risk factors for chronic diseases.
Darlene is excited to bring her expertise to the regulatory world and support TSG clients with state registrations and renewals. Darlene graduated from Sacramento State University with a BS in Nutrition.
Job Titles:
- Dean
- Regulatory Consultant
Dean Moser is a Regulatory Consultant in our California office who specializes in obtaining and maintaining state registrations. He has an especially in-depth knowledge on FIFRA 25(b) Exempt state registration work and is adept at handling all the challenges that come with these products.
He thoroughly enjoys helping clients work through the registration process and guiding them through the intricate learning curve of state registrations. Dean has 12 years' experience in the pesticide regulatory industry, supporting EPA Federal registrations, obtaining, and maintaining California, New York and Florida registrations and managing client state inventories.
Dean has a BS in Leisure Studies from the University of Iowa and a M.Div. from Bethel Seminary.
Harold Stowe is a Regulatory Consultant supporting clients with compliance to US EPA and FDA federal regulation. Harold specializes in pre- and post-market compliance for chemical and mechanical antimicrobial technologies under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). Harold also supports TSG's FDA Medical Device clients, leading companies in the development and execution of strategies to navigate FDA's medical device premarket authorization pathways - 510(k) Premarket Notification, De Novo, and PMA.
Harold previously worked in regulatory compliance in the animal agriculture space, working with industry stakeholders to address food pathogen and phytosanitary compliance concerns in the production, import, and export process. He brings regulatory and legislative experience from industry, knowledgeable in organizing and managing grassroots campaigns, orchestrating public-private research initiatives, and participating with USDA and FDA stakeholder coalitions. Harold has a Bachelor of Science in Economics, and Bachelor of Science in Agribusiness from Clemson University.
James Bozeman joins TSG as a Regulatory Specialist. He specializes in state registration and renewals for pesticides, fertilizers, amending materials, and animal feed. He has previous experience leading regulatory inspections with state authorities such as California's Department of Public Health and Department of Food and Agriculture
James' experience includes operational permit applications and renewals, risk mitigation, and traceability management in the speciality crop industry. James' previous work in regulatory compliance with high-volume, agriculturally based companies lends well to his detail-oriented work with TSG's clients.
Job Titles:
- Regulatory Consultant and Canadian Agent
- Senior Regulatory Consultant and Canadian Agent
Joe McCarthy joins TSG as a Senior Regulatory Consultant and Canadian Agent. With over 20 years of experience, Joe specializes in Canadian consumer and commercial regulatory affairs.
Joe provides service and solutions to clients for product registration and compliance for a variety of conventional, non-conventional, and pesticide device products in Canada. Joe has a keen understanding of Canadian regulation including the Pest Control Products Act, Fertilizers Act, New Substance Notification Regulations, as well as Consumer and Workplace Chemical labeling and disclosure. In addition to his knowledge of Canadian legislation, Joe is also well-versed in US regulations. Joe holds a BSc in Chemistry and Environmental Sciences.
Job Titles:
- Principal Regulatory Consultant
Jonathan Walsh joins TSG as a Principal Regulatory Consultant, providing regulatory and registration support to antimicrobial clients.
Prior to joining TSG, Jonathan worked as a Senior Manager of Regulatory Affairs at Arxada (formerly Lonza). He gained experience in antimicrobial registrations, specializing in environmental hygiene products. Jonathan combines his background in chemistry along with the regulatory experience to review projects and develop successful registration strategies, submit federal registration packages, develop acceptable label claims, and coordinate product testing. Jonathan has a BSc in Chemistry from Florida State University.
Job Titles:
- Senior Regulatory Consultant
Julie Ownbey specializes in pesticide compliance with a focus on federal registration for antimicrobial products. She has experience working with Canadian pesticide registrations through PMRA and has experience with the regulatory compliance of medical device and drug products.
Julie has over 18 years' experience working in regulatory compliance and product submission, developing and deploying regulatory policies and procedures for various products. She has previous experience with treated article exemptions under FIFRA and has managed sub-registrations for pesticide products.
Julie has a BS in Environmental Health from East Tennessee State University.
Job Titles:
- Managing Director, State Affairs & Head of TSG California
Kelly Rahn specializes in the registration and ongoing compliance of pesticides at the US state and federal level, with an emphasis on antimicrobials and conventional chemicals for all major market sectors including agrochemical, consumer, structural pest control, and the industrial/institutional marketplace. She is also well versed in FIFRA's Good Laboratory Practices (GLP) and 6a2 compliance.
Kelly leads an important sector of TSG's work - state affairs. With the experience gained from working for over 30 years in the pesticide industry combined with her scientific background in chemistry, Kelly assists our clients with all aspects of state regulation. These include: navigating the complex data requirements imposed by California Department of Pesticide Regulation (CDPR) and other state regulatory bodies; resolving labeling and efficacy issues for biostimulants, pesticide devices and minimum risk pesticides; developing economically beneficial data compensation strategies; and maintaining valuable registrations for hundreds of clients through deadline management for product registrations, license renewals and tonnage reporting. Given her proximity and expertise in state regulation, Kelly has strong working relationships with CDPR and is a member of the Western Plant Health Association.
Kelly has a BS in Chemistry from the University of Dallas.
Job Titles:
- Vice President and Principal, Medical Device Regulatory
Laurie Clarke leads TSG Consulting's medical device regulatory practice. Her knowledge and experience as a former FDA lawyer enable her to be an effective adviser and advocate for clients throughout the device lifecycle.
Laurie specializes in helping device companies develop and implement regulatory strategies that meet their marketing objectives. A former FDA partner at three top-ranked law firms, Laurie is a recognized leader in medical device regulations, spanning from premarket submissions to FDA enforcement actions.
Throughout her career, Laurie has assisted clients with 510(k) premarket notifications, investigational device exemptions (IDE), premarket approval applications (PMA), de novo review submissions, pre-submissions, requests for designation of combination products as devices, and 513(g) requests. She has extensive experience preparing clients for FDA meetings, as well as representing them at such meetings. Laurie has a proven track record of obtaining FDA clearance or approval to market and conduct clinical (human) testing of a wide range of medical devices. In addition, Laurie has helped companies register their establishments, list their devices, and evaluate modifications to marketed products. She has also helped device manufacturers prepare for FDA inspections, comply with medical device reporting requirements, promote their products without making off-label claims, and conduct recalls.
Prior to joining TSG Consulting, Laurie was Executive Vice President of Medical Devices & Combination Products at Greenleaf Health. She has also been an FDA partner at Jones Day, King & Spalding and Hogan & Hartson, all international law firms with top medical device practices. She started her career as an FDA lawyer at Patton, Boggs, and Blow, a law firm that combined legal representation with lobbying for policy changes.
Laurie earned a JD from Stanford University, an MPP with a concentration in Health Policy from Harvard University, and an AB cum laude from Smith College.
Job Titles:
- State Services
- State Services / Hungary Poland Slovakia Slovenia US - State Services USA
Luke is based in Sacramento, CA.
In his previous role as Commercial Support Manager, he worked across TSG's European sites to improve existing and develop new commercial processes and procedures.
Prior to joining TSG, Luke was a Consultant in Regulatory Affairs at ERM. He has a degree in Cellular and Molecular Biology from Newcastle University and a PhD in Plant Physiology from the University of Sheffield. As part of his PhD, Luke was a Research Associate at Bayer Crop Science in Frankfurt.
Job Titles:
- Senior Scientific Consultant
Manuela joins TSG as a Regulatory Consultant, providing regulatory and registration support to clients.
Prior to joining TSG, Manuela worked as a Senior Regulatory Affairs Specialist at Medline Industries, LP where she managed Medline's EPA registered products portfolio. Manuela has a Chemical Engineering degree in Monomers and Polymers Technology from Technical University Timisoara, Romania.
Mr. Richard Kendrick is a Regulatory Specialist at TSG. He specializes in state registration and renewals for pesticides, fertilizers, amending materials, and animal feed. He has substantial experience managing state renewals for plant protection and health products, reviewing labels, and filing tonnage reports with relevant state agencies, including the California Department of Food and Agriculture (CDFA).
Mr. Kendrick also develops and maintains internal databases that allow for easy access and management of appropriate records. These databases enable consultants to track upcoming deadlines and communicate registration status to clients regarding submitted products.
Education
B.A., English - University of California, Davis
Perri Moeller is a Regulatory Consultant supporting clients with US EPA federal regulatory compliance focusing on Antimicrobial Pesticide registrations under the framework of the US Federal Insecticide, Fungicide and Rodenticide Act (FIFRA).
Before joining TSG, Perri worked at the US EPA in the registration of FIFRA products. She worked with industry stakeholders in shepherding submission packages through the EPA registration process. While at the agency she focused her efforts on List-N Registrations for Covid and on the joint OPPT and OPP Design for the Environment (DfE) program rebranding campaign in connection with SaferChoice. Perri Has her Bachelor of Arts in Marine Affairs and Policy, Ecosystem Science and Policy from the University of Miami. She is currently an MBA Candidate at the University of Maryland.
Pete Stevenson specializes in the compliance of animal feed and pet food products at the national and state levels. Pete also works in the compliance of plant protection products including pesticides.
Pete previously worked as a regulatory affairs professional in the animal health industry developing global regulatory strategies for new products and maintaining existing product licenses. He has experience with feed ingredient registrations worldwide, specializing in the United States and Canada. He also has experience authoring GRAS dossiers for US feed ingredients and development of CMC sections of dossiers to be used globally.
Pete has a B.S. and M.S. in Chemistry from Furman University in South Carolina.
Job Titles:
- General Manager
- General Manager of TSG North America
- President - Science Group North America
Ryan Gaunt is the General Manager of TSG North America and the President of North America for Science Group. A lawyer by practice, Ryan is responsible for the commercial success of TSG Consulting, as well as Science Group's North American Operations.
Ryan is approaching 20 years of experience in business development, sales, and executive leadership within the technology, innovation, medical and regulatory spaces. He started his career in sales at GE Healthcare and Philips Medical Systems, prior to owning his own consultancy providing legal and business guidance for small and emerging businesses across multiple industries. Over the past 10 years at Science Group, Ryan has dedicated his time to supporting multinational companies realize their opportunities for growth. An accomplished leader, Ryan excels at building and managing successful teams in the industrial, chemical, and energy markets. Ryan has a BS in Marketing and Sales from Purdue University, as well as a Juris Doctor (JD) in Commercial Law and an MBA from Suffolk University.
Job Titles:
- a Regulatory Specialist
- Regulatory Specialist
Taylor Metts-Houston joined TSG as a Regulatory Specialist. In this role, she supports product registrations and tonnage reports for fertilizer, amending materials and animal feed products across the US.
Taylor is experienced in project management and laboratory research; and has also assisted business owners with marketing and business development. Her past laboratory research was with the Prevention Research Center Alcohol and Skin Cancer Projects at Pennsylvania State University. She is dedicated to providing an excellent service.
Job Titles:
- Principal Consultant
- Principal Regulatory Consultant
Wendy joined TSG as a Principal Consultant, providing regulatory and registration support to conventional and biopesticide clients.
Prior to joining TSG, Wendy worked as a consultant for over 30 years. She has provided regulatory strategies and solutions for more than 300 different chemical companies to help them maintain compliance with Federal and State requirements. While she has assisted clients with TSCA, FDA, and USDA matters, most of her work has involved managing the FIFRA requirements for antimicrobial products, conventional pesticides, biopesticides and inert ingredients. Wendy has a BS in Biology from Gettysburg College.