Regulatory Affairs Expert Witnesses in Arizona

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Regulatory affairs expert witnesses practice in a variety of fields, including pharmaceuticals, medical devices, biotechnology, and healthcare compliance. Some of the most common specialties include FDA regulations, EMA guidelines, product approvals, labeling, advertising, and post-market surveillance. They can opine on the effects of regulatory noncompliance, enforcement actions, product recalls, and patient safety risks.

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  • This highly qualified check fraud specialist and certified anti money laundering specialist has over 21 years of service in the industry. He spent 10 years as a Nevada law enforcement official in the field of corrections, and reserve work and became the president of the Nevada Check Cashing Association and board member of the National Check Cashers Association. He is currently a member of the Nevada Fight Fraud task force and Consumer Affairs Investigator Reserve as well as previous member Anti Money Laundering MSB task force. He currently provides anti-fraud consulting services nationally as well ad AML training, drafting of AML programs and independent reviews and written risk assessments.

    Check Cashing Fraud Consultant, A major money fraud consulting firm

    Las Vegas,

    Nevada

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  • Review Fee $250/hr
    Deposition Fee $310/hr
    Court Fee $310/hr

    This Nutrition industry professional has an advanced degree in nutrition, and several years of experience involving the technical aspects of regulatory affairs, scientific affairs, product labeling, and research & development. His specialties: 21 CFR 101 (Food Labeling), 21 CFR 111 (cGMPs for dietary supplements), FTC advertising guidelines, regulatory compliance review, product substantiation, ingredient research and product development. In his current role as Manager at a Vitamin research company he is responsible for reviewing products, labeling and marketing materials for FDA and FTC compliance.

    VP, A dietary supplement company in ID

    Master of Science (MS), University of Saint Joseph

    Eagle,

    Nevada

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  • Review Fee $350/hr
    Deposition Fee $350/hr
    Court Fee $350/hr

    This highly qualified expert has extensive knowledge of regulatory and legislative issues relating to the healthcare industry and of eHealth governance. He received both his MAS and PhD degrees focusing in health policy and law and global health from the University of California, San Diego, and has worked as a consultant or expert for various organizations including the World Health Organization, US Department of State, US Department of Justice and others. He is a member of various professional organizations, including the American Public Health Association and is the current program chair of the APHA Trade and health forum. He lectures both nationally and internationally and has received multiple honors for his outstanding research. He has published 100+ peer-reviewed journal articles and serves on the editorial board at BMC Medicine and is an associate editor at BMC Public Health. He is the former senior research associate at the California Western School of Law's Institute of Health Law Studies and the former senior legal and compliance specialist at ResMed Inc. Currently, he is the director of a major health policy research institute and an assistant professor of global public health at a major school of medicine, where he also directs the master's degree program in health policy and law.

    Assistant Professor, Major University

    Doctor of Philosophy (PhD), University of California San Diego

    San Diego,

    California

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  • Review Fee $400/hr
    Deposition Fee $500/hr
    Court Fee $500/hr

    This FDA regulation expert earned her B.S. in Environmental Chemistry from Purchase College and her M.S. in Environmental Science from the University of Colorado Denver. She began her career with the FDA in 1987 as a Chemist in the Denver Districts Laboratory and then became a Compliance Officer in 1992, specializing primarily in medical device and biologics cases. She later managed a group of eight investigators as a Supervisory Consumer Safety Officer and then became a Compliance Officer, tasked with evaluating reports and lab analysis to determine compliance with regulation. The expert finished her FDA career as a Senior Case Review Expert, a role she held from 2008 until the end of 2015. In this position, she was responsible for reviewing and evaluating proposed judicial actions to determine if they were compliant with the requirements of the the Federal Food, Drug, and Cosmetics Act and other regulations. Currently, the expert runs her own consulting business.

    Principal and Owner, A Regulatory Compliance Consultancy in CO

    Master of Science (MS), University of Colorado

    Littleton,

    Colorado

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  • Review Fee $350/hr
    Deposition Fee $400/hr

    This expert has over 10 years of experience in risk management and regulatory compliance in the financial services industry, with a focus on identifying compliance issues and implementing solutions to mitigate risk. In his work with the CFPB, he identified millions of dollars in remediation for consumers. Formerly, he worked in consumer protection roles with the Consumer Financial Protection Bureau and the California Department of Financial Institutions, as well as in compliance and risk management roles at San Diego County Credit Union and Union Bank. Currently, he is a compliance advisor with a national financial services group and is based in California.

    Compliance Advisor, A National Financial Services Group

    Graduate, American Banker Association Graduate School

    San Marcos,

    California

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What Can a Regulatory Affairs Expert Witness Opine On?

Regulatory Submissions

Prepare and submit regulatory documents.

Labeling Compliance

Ensure product labels meet regulations.

Risk Assessment

Evaluate potential risks of products.

Clinical Trial Applications

Submit applications for clinical trials.

Quality Management Systems

Implement and maintain quality systems.

Regulatory Strategy Development

Create strategies for regulatory approval.

FAQs for Regulatory Affairs Expert Witnesses

What is a regulatory affairs expert witness?

A regulatory affairs expert witness is a specialist in FDA, EMA, and other compliance rules who explains standards and industry practices. They assist by reviewing records, preparing reports, testifying, and clarifying complex regulatory issues.

In what case types can a Regulatory Affairs expert witness provide valuable assistance?

A Regulatory Affairs expert witness assists in FDA and EMA compliance, drug and device approval, labeling, clinical trials, pharmacovigilance, manufacturing, and product liability cases.

How can a regulatory affairs expert witness evaluate FDA compliance in disputed submissions?

A regulatory affairs expert witness evaluates FDA compliance in disputed submissions by reviewing documentation, regulations, correspondence, and processes to identify gaps and support or challenge claims.

What qualifications should counsel require from a regulatory affairs expert witness?

Counsel should require a regulatory affairs expert witness to have advanced regulatory credentials, industry experience, prior testimony, and deep knowledge of relevant agency rules.

How does a regulatory affairs expert witness assess adequacy of product labeling controls?

A regulatory affairs expert witness assesses adequacy of product labeling controls by reviewing procedures, change controls, training, audits, and compliance with FDA and industry standards.

What is Expert Institute’s process for selecting regulatory affairs expert witnesses?

Expert Institute delivers a tailored approach to connect you with top-tier experts. We identify actively practicing professionals who meet your exact criteria for specialty, experience, litigation background, fee structure, credentials, location, and more.

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