Toxicology and Regulatory Consulting

Highly qualified, professional toxicologists with specialized

regulatory expertise:

Interface with regulatory authorities on global biocide, pesticide, food contact, food additive, and pharmaceutical approvals

Manage US and international notification and registration programs for chemicals, food additives, drugs, and medical devices

Define and manage safety testing programs for chemicals, food additives, and drug candidates

Design, implement, monitor, and scientifically evaluate studies

Conduct hazard, exposure, and risk assessments for various applications

Provide scientific advice and technical support on special issues

TRS Services Will Accomplish Your Regulatory Objectives

Toxicology Regulatory Services, Inc.154 Hansen Road, Suite 201

Charlottesville, Virginia 22911 USATelephone: +1 434.977.5957Facsimile: +1 434.977.1856E-mail: trs@toxregserv.com

Website: www.toxregserv.com

The TRS office is conveniently located in the heart of Virginia, approximately 100 miles from Washington, DC.

3/2020

Quality Assurance ConsultingRegistered Quality Assurance

Professionals (RQAP-GLP) with diverse scientific and technical

experience:

Provide expert guidance on EPA, FDA, and OECD Good Laboratory Practices (GLPs)

Evaluate Good Clinical Practice (GCP) systems and procedures

Conduct protocol, raw data, and report audits for GLP, GCP, and test guideline compliance

Perform facility and in-process inspections for GLP and GCP compliance

Design and implement GLP training programs

Prepare SOPs for GLP and test guideline compliance

Offer Quality Assurance oversight for all toxicology, chemistry, and environmental fate and effects study designs

Uncompromising commitment to the highest quality

consulting service

Established 1991

Ms. Rihner joined TRS in 2002 after earning her BA in Biology from the University of Virginia. Ms. Rihner directs the activities supporting the full range of services provided by TRS, including conducting literature and regulatory searches, establishing and maintaining client databases, performing consumer exposure assessment and hazard analysis, preparing scientific presentat ions, monographs and manuscripts for publication, managing Expert Panel reviews and meetings, and coordinating regulatory submissions for food additives, flavor ingredients, and chemicals. Ms. Rihner also participates in the design and management of regulatory testing programs by assisting in evaluation of US and international regulatory policy, study protocol development, monitoring of overall study conduct, and addressing technical issues on behalf of the Sponsor. As a QA auditor, she performs raw data and draft report reviews, inspections of contracted testing facilities, and training for compliance with GLPs and GCPs.

Mr. Burruss joined TRS in 2013 with a BS in Chemistry from the University of Mary Washington (UMW) and is currently in a masters degree program in the Department of Environmental Sciences at the University of Virginia. His graduate studies are focused on environmental chemistry and related issues. Following graduation from UMW, Mr. Burruss spent two years employed at Universal Laboratories, where his career advanced from Laboratory Technician to Technical Director. At TRS, Mr. Burruss contributes to the design, management, and monitoring of ecotoxicology, environmental fate, physical-chemical properties, product chemistry, and analytical method validation studies. As a quality assurance (QA) auditor, he conducts GLP raw data audits and draft study report reviews for various analytical chemistry and toxicology studies. In addition, he assists with the preparation of health/environmental risk assessments and regulatory submissions for food additives, flavoring ingredients, biocides, pesticides, and medical devices. Other responsibilities include preparing safety evaluations of pharmaceutical and cosmetic ingredients (including ADEs, OELs, etc.), conducting literature searches, and performing technical and scientific reviews of manuscripts.

Dr. Nikiforov has more than 30 years of experience in toxicology and environmental health sciences conducting research, as a corporate advisor and as a consultant. He has been with TRS since 1997 where he manages toxicology programs and issues, offers regulatory expertise, and provides support for product stewardship. At TRS, he has provided scientific and regulatory support in various areas including flavoring ingredients, direct and indirect food additives, biocides, metals, plasticizer chemicals, and pharmaceutical intermediates for clients of the consumer products, specialty chemicals, and pharmaceutical industries. Dr. Nikiforov has a strong inhalation toxicology background and experience from graduate studies at New York University, and further developed at Battelle Research Center (Geneva). Subsequently, he was a toxicology advisor and manager at Exxon Biomedical Sciences, Inc., addressing issues for chemical company affiliates, particularly during an assignment in Brussels as European toxicology advisor on EU regulatory and risk assessment programs. Dr. Nikiforov has coauthored more than 30 peer-reviewed publications and reports. He is currently a member of the international editorial board of Food and Chemical Toxicology.

Andrey I Nikiforov, PhDSenior Scientific Advisor

Ms. Fisher joined TRS in 1999 and has more than 30 years of experience in toxicology testing and GLP study monitoring and compliance. In her current position, Ms. Fisher manages QA and scientific consulting services at TRS, monitors toxicology studies from protocol development through final reporting, and provides QA services to Sponsors and testing facilities, including data and report auditing, facility inspections, and training for US and OECD GLP compliance. In addition, she assists with the preparation of US and international chemical/product registration submissions and pharmaceutical product risk assessments, and evaluates medical device biocompatibility studies for ISO-compliance. Prior to joining TRS, Ms. Fisher had a successful career at Bushy Run Research Center where she held various positions of increasing responsibility, from Technician to Supervisor of Developmental/Reproductive Toxicology and was responsible for coordinating GLP studies, supervising laboratory personnel, evaluating study data, implementing GLP procedures, and validating data acquisition computer programs. Prior to her employment at Bushy Run, Ms. Fisher earned her BS in Biology from Allegheny College.

Louan C Fisher, RQAP-GLPSenior Managing Consultant QA and Scientific Affairs

Marisa O Rihner, RQAP-GLPSenior Managing Consultant QA and Regulatory Affairs

Benjamin L Burruss, RQAP-GLPSenior Consultant

Keith A Hostetler, PhDSenior Managing ToxicologistDr. Hostetler joined TRS in 2010. He provides support for registration of biocides, pesticides, and specialty chemica l s, inc lud ing sc ient i f i c monitoring of data development programs, preparing risk assessments, and coordinating interactions with global regulatory agencies. Other responsibilities include preparation and submission of dossiers for international chemical review programs, designing and implementing data development programs, conducting literature evaluations, and recommending new or ongoing research. Prior to joining TRS, Dr. Hostetler was Vice President of Regulatory Affairs for Microban International, responsible for product safety and regulatory compliance programs related to US EPA, US FDA, and the EU Biocidal Products Directive. He held a variety of technical, regulatory, and commercial positions during a 17-year tenure with Swiss-based Ciba Specialty Chemicals in the areas of specialty additives for personal care products, medical devices, and other industrial applications. Dr. Hostetler has also worked in the food industry, focusing on safety and regulatory issues related to foodstuffs and synthetic food and nutritional additives. He earned his BS and PhD degrees at the Medical College of Virginia, Virginia Commonwealth University.

The curricula vitae of our scientific staff are available online at: www.toxregserv.com

Ms. Parker joined TRS in 2018 with a BA in Chemistry from Virginia Tech. Following graduation, Ms. Parker spent one year employed at Perrigo Nutritionals, where she became well versed in infant formula regulations. Ms. Parker then worked for a biotechnology company, BIO-CAT, for four years where her career advanced from Regulatory Affairs Associate to Regulatory Affairs Manager. During her tenure at BIO-CAT, Ms. Parker participated in various industry organizations such as the Enzyme Technical Association (ETA), where she became chair of the Dietary Supplement Committee. At TRS, Ms. Parker conducts literature and regulatory searches, establishes and maintains client databases, performs consumer exposure assessments and hazard analyses, prepares scientific presentations, monographs, and manuscripts for publication, supports development and evaluation of client regulatory strategies and assessments through research, review, and application of US and international regulations, performs raw data and draft report reviews of toxicology and clinical research studies, manages Expert Panel reviews and meetings, and coordinates regulatory submissions for food additives, flavor ingredients, and chemicals.

Julia M ParkerSenior Consultant

G Craig Llewellyn, PhDPrincipal and Scientific DirectorDr. Llewellyn has more than 25 years of experience in toxicology, analytical food chemistry, scientific and regulatory affairs, designing and conducting scientific research, and product development from positions in academia; food, pharmaceutical, and coatings corporations; and state government. He has been with TRS since October 2018 where he provides scientific and regulatory evaluations and support in various areas including direct and indirect food additives, flavorings, food allergens, ingredients, and precursors used by food and beverage, consumer products, specialty chemicals, and pharmaceutical industries. Dr. Llewellyn has a background in immunotoxicology, toxicology, and pharmacology from graduate studies at Medical College of Virginia, Virginia Commonwealth University and post-doctoral training with Eli Lilly and Co. He also has held positions with ingredient and product safety and global scientific and regulatory affairs responsibilities for Kraft Foods, The William Wrigley Jr. Company, and The Coca-Cola Company. Dr. Llewellyn has participated in and held leadership positions in numerous trade and scientific organizations and coauthored or sponsored more than 100 peer-reviewed publications and reports.

Ms. Weston first joined TRS in 1993 after earning her BS in Biology from Gettysburg College and spending a year in the Ph.D. program in Cell Biology at University of Virginia. During her initial eight years with TRS, Ms. Weston oversaw antimicrobial and agrochemical testing programs conducted within the US and internationally. Her specific area of expertise was environmental fate, residue chemistry, metabolism, and product chemistr y studies. Subsequently, Ms. Weston took an extended leave from the consulting field, during which time she developed her business management and marketing skills. Ms. Weston returned to TRS in May 2019 and provides regulatory and technical services for food additives, flavor ingredients, and chemicals; conducts literature and regulatory searches; assists in writing safety dossiers and manuscripts for publication; and participates in the monitoring of studies conducted in support of regulatory testing programs.

Sari L WestonSenior Consultant