Regulatory Affairs Expert Witnesses

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Regulatory Affairs expert witnesses practice in a variety of fields, including pharmaceuticals, medical devices, biotechnology, food safety, and environmental regulations. Some of the most common specialties among Regulatory Affairs expert witnesses include clinical trials regulation, drug approval processes, FDA compliance, product labeling regulations, and quality assurance. They can opine on the effects of regulatory violations, non-compliance penalties, product recalls, adverse event reporting, and regulatory strategy development.

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Timothy Alan Ulatowski, MSView profile

ID: 701648

Mr. Timothy Alan Ulatowski, MS

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Virginia

Mr. Timothy A. Ulatowski has 48 years of experience in the Regulatory and Compliance Industry. He earned his BS in Microbiology from Pennsylvania State University and his MS in Physiology from Georgetown University. Formerly, this expert served as the Director of the Division of Dental, Anesthesiology, General Hospital, and Infection Control Devices and as the Director of the Office of Compliance...

Financial Services Regulatory Compliance Expert Witness | CaliforniaView profile

E-608192

Financial Services Regulatory Compliance Expert Witness | California

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California

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...

Brent Roland BowersView profile

ID: 5790443

Mr. Brent Roland Bowers

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Pennsylvania

Mr. Brent R. Bowers has over 28 years of experience in the field of Healthcare Administration and Operations. He earned his BA in Sociology from the California State University Northridge. Formerly, this expert served as the Facility Administrator and Operations Manager at Passages Malibu and as the Director of Business Development at Las Encinas Hospital. Currently, he serves as the Chief...

Financial Regulations and Check Cashing Expert Witness | NevadaView profile

E-006755

Financial Regulations and Check Cashing Expert Witness | Nevada

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Nevada

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...

Pharmaceutical and FDA Regulations Expert Witness | GeorgiaView profile

E-007167

Pharmaceutical and FDA Regulations Expert Witness | Georgia

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Georgia

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Massachusetts

This expert has over 40 years of experience in the Pharmaceutical and Pharmaceutical Packaging industries. He has published five books and has instructed professionals at the graduate level in Quality Assurance and Regulatory Affairs at a major university's pharmacy school. As a former Director of the Science Branch of the Philadelphia District FDA, he directed a laboratory staff of 30 in methods...

Regulatory Affairs and Product Labeling Expert Witness | NevadaView profile

E-008723

Regulatory Affairs and Product Labeling Expert Witness | Nevada

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Nevada

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,...

Global health Expert Witness | CaliforniaView profile

E-028298

Global health Expert Witness | California

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California

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,...

FDA Medical Device Regulatory Requirements Expert Witness | IllinoisView profile

E-030330

FDA Medical Device Regulatory Requirements Expert Witness | Illinois

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Illinois

This highly qualified expert has over 20 years of FDA experience encompassing virtually all of the FDA field positions. He also has 18 years of industry experience as a mid-level Manager and Senior Executive in clinical, regulatory, and quality in the medical device industry. He has personally designed quality systems, prepared regulatory submissions, and managed 7 multi-center clinical trials...

Medical Devices & Bioengineering and Regulatory Affairs Expert Witness | MassachusettsView profile

E-032781

Medical Devices & Bioengineering and Regulatory Affairs Expert Witness | Massachusetts

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Massachusetts

This expert received his undergraduate and doctoral degrees in Biomedical Engineering from Iowa State University. He has worked for and consulted with leading medical device, pharmaceutical & biotechnology companies ranging in size from start-ups to Fortune 100 companies. He also works on a regular basis for the FDA, Health Canada, the US & European Patent Offices, the Centers for Medicare and...

Safety Expert Witness | TexasView profile

E-037177

Safety Expert Witness | Texas

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Texas

This highly qualified expert has more than 40 years of international experience in the development and implementation of occupational health, safety, and environmental (HSE) management systems within the petroleum, petrochemical,manufacturing, and construction industries. He is an advisor to management on regulatory compliance with worldwide agencies such as BSEE, EC, OSHA, HSE, PSA, SSM, DEA,...

FDA Regulatory Affairs & Medical Devices Expert Witness | ConnecticutView profile

E-053014

FDA Regulatory Affairs & Medical Devices Expert Witness | Connecticut

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Connecticut

This certified Regulatory Affairs Professional has more than 20 years of experience ensuring compliance with the FDA. Throughout his career, he has managed 510(k) submissions, reviews, appeals, and clinical trials for a multitude of devices with applications ranging from dentistry to cardiology and neurology. Prior to launching his current consultancy, he served as a Director of Regulatory...

FDA Regulations Expert Witness | ConnecticutView profile

E-056391

FDA Regulations Expert Witness | Connecticut

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Connecticut

This expert is currently working through her consulting company, within the Pharmaceutical Industry as a consultant, providing guidance and service for all aspects of Regulatory Affairs for the entire product lifecycle of drugs and biologics from discovery to approval/launch and post-marketing. In addition, providing expertise in business development pertaining to regulatory intelligence and...

FDA Regulatory Affairs Expert Witness | MarylandView profile

E-057945

FDA Regulatory Affairs Expert Witness | Maryland

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Maryland

A 17-year veteran of the U.S. Food and Drug Administration (FDA), this expert served as the Regulatory Counsel to the Associate Commissioner for Regulatory Affairs, and previously, in scientific, inspectional, compliance and criminal and civil enforcement capacities as an FDA Consumer Safety Officer (CSO), Compliance Officer (CO), a Senior Special Agent (SA) with the Office of Criminal...

FDA Regulation and Compliance Expert Witness | ColoradoView profile

E-065690

FDA Regulation and Compliance Expert Witness | Colorado

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Colorado

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...

New York State DMV Regulations Expert Witness | New YorkView profile

E-070246

New York State DMV Regulations Expert Witness | New York

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New York

This former New York DMV manager has decades of experience working for the Department of Motor Vehicles. He held positions as a Clerk and Operations Manager in the White Plains and Albany offices in the 1980s and became Office Manager of the New York District Office in 1993. For 12 years, he served as the District Director in charge of operations in the MetroNorth District, and he finished his...

FCC & Communications Law Expert Witness | District of ColumbiaView profile

E-074631

FCC & Communications Law Expert Witness | District of Columbia

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New Hampshire

This expert regularly counsels clients on regulatory, transactional and legislative issues affecting the broadcasting, wireless and wireline industries. He is an active member of the Federal Communications Bar Association, for which he has served on the Executive Board since 2013. He also authors a monthly column in Radio Magazine, is editor of a telecom blog, and speaks regularly on panels,...

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Pharmacy Regulations Expert Witness | New YorkView profile

E-028376

Pharmacy Regulations Expert Witness | New York

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New York

This extremely qualified expert is a certified pharmacist with years of experience in community pharmacy management and regulatory affairs. He received both his BS degree in pharmacy and his MBA degree from the University at Buffalo. He is a member of multiple professional associations, including the American Association of Colleges of Pharmacy, the American Pharmacists Association and the...

FDA Regulations  Congressional oversight Expert Witness | WisconsinView profile

E-074885

FDA Regulations Congressional oversight Expert Witness | Wisconsin

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Wisconsin

This expert is the president of a healthcare government relations and regulatory policy consultancy firm that she founded after an extensive career in healthcare and government. She was the Vice President for Government Relations and Public Policy at Celgene and was the Vice President for Regulatory Policy at GE Healthcare. She served in the administration of President George H.W. Bush as Special...

Clinical Psychopharmacology & Clinical Research Expert Witness | MarylandView profile

E-082090

Clinical Psychopharmacology & Clinical Research Expert Witness | Maryland

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Maryland

This expert received his BA from Cornell University, and his MD and PhD from Albert Einstein College of Medicine. He completed his residency in Psychiatry at UCLA Neuropsychiatric Institute/Brentwood VA Medical Center. He is also a member of numerous academic societies including American Society of Addiction Medicine, American Academy of Addiction Psychiatry, Society of Biological Psychiatry,...

Construction safety and OSHA regulations Expert Witness | TennesseeView profile

E-300743

Construction safety and OSHA regulations Expert Witness | Tennessee

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Tennessee

This qualified expert received his BA from Valparaiso University and is a licensed OSHA trainer for numerous courses. He has managed various construction safety projects including the installation and modification of industrial equipment valued at over a billion dollars. Formerly, he served as a night safety manager for Gallagher Kaiser at General Motors and as a safety manager for NKC American...

Regulatory Affairs Expert Witness FAQs

What is the role of a Regulatory Affairs expert witness?

A Regulatory Affairs expert witness provides insight and testimony on matters related to regulatory compliance, product approval processes, and industry standards in various sectors.

In what types of cases can a Regulatory Affairs expert witness be beneficial?

These experts are crucial in cases involving pharmaceuticals, medical devices, food safety, environmental regulations, and any sector where regulatory compliance is key.

How can a Regulatory Affairs expert witness assist in a pharmaceutical case?

They can provide insights into FDA approval processes, drug safety regulations, labeling requirements, and other aspects of pharmaceutical regulatory affairs.

Are there subspecialties within the field of Regulatory Affairs that an expert witness might focus on?

Yes, some experts may specialize in specific areas like pharmaceuticals, medical devices, biotechnology, or environmental regulations depending on their experience.

Why is it important to have a Regulatory Affairs expert witness with industry-specific knowledge?

Industry-specific knowledge ensures the expert is familiar with the unique regulatory landscape of that sector, providing accurate and relevant testimony.

How does Expert Institute select its Regulatory Affairs expert witnesses?

Expert Institute offers a personalized approach to help you find the highest quality experts. We source actively-practicing professionals who match all your requirements for specialty areas, work experience, litigation history, fee range, certifications, location, and more.

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