Regulatory Affairs Expert Witnesses

ID: 518086

Maryland

Dr. Christine L. Brauer has 34 years of experience in Medical Devices and Healthcare Regulation & Compliance. She earned her BA in Biology from the University of Delaware, her MS in Microbiology and Molecular Biology from the University of Virginia, and her PhD in Women's Health and Research Methods from the University of Maryland, College Park. Formerly, this expert served as the Vice President...

E-608192

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...

ID: 5790443

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...

E-006755

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...

ID: 6220515

Hawaii

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District Columbia

Ms. Katherine C. Norris has 20 years of experience in the fields of Life Sciences and Corporate Compliance. She earned her BA in Telecommunications and Film from the University of Alabama, and her MPA in Public Policy and Law from the University of Tennessee Knoxville. Formerly, this expert served as the Senior Director of the Compliance and Integrity Programs at NSF Health Sciences, as the...

E-007167

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...

ID: 663796

Mississippi

Mr. Robert Church has 39 years of experience in Forensic Accounting and Fraud. He earned his BBA in Accounting and Management from the University of Mississippi, his MS in Law from California Southern University, and in Forensic Psychology from Northcentral University. Today, this expert is certified as a Certified Forensic Accountant by the American Board of Forensic Accounting. Formerly, this...

E-008723

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,...

ID: 6743128

Maryland

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District Columbia

Mr. Steven D. Silverman has 31 years of experience in Healthcare Regulatory and Compliance. He earned his BA from the University of Michigan and his JD from the University of Pennsylvania Carey Law School. Today, this expert is licensed as an Admission to Practice Law in the District of Columbia. Formerly, this expert served as the Director of the Center for Devices and Radiological Health of the...

E-028298

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,...

ID: 701648

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...

E-030330

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...

E-032781

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...

E-037177

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,...

E-053014

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...

E-056391

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...

E-057945

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...

E-065690

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...

E-070246

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...

E-074631

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,...