REGULATORY AFFAIRS EXPERT WITNESSES

Expert Witness: E-300743
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 at Toyota Motor Manufacturing. He currently is the safety manager for a ...
Expert Witness: E-082090
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, College of Problems of Drug Dependence and American Psychiatric Association. ...
Expert Witness: E-074885
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 Assistant for Legislative and Public Affairs in the Office of the ...
Expert Witness: E-028376
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 American Society for Pharmacy Law. He has given 100+ lectures statewide in NYS. ...
Expert Witness: E-074631
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, including the National Association of Broadcasters, state broadcast ...
Expert Witness: E-070246
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 career in the DMV as the Regional Director in charge of the Metropolitan ...
Expert Witness: E-065690
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 ...
Expert Witness: E-056391
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 regulatory due diligence. Her experience includes serving as a member of the ...
Expert Witness: E-057945
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 Investigations (OCI) and as an analytical regulatory microbiologist. During his last ...
Expert Witness: E-053014
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 Affairs at medical device firms that manufacture class II and class III products. ...
Expert Witness: E-037177
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, USCG, MSHA, MMS, NOPSA and other applicable industry standards and codes. He ...
Expert Witness: E-032781
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 Medicaid Services, and other regulatory agencies around the world. As an ...

REGULATORY AFFAIRS EXPERT WITNESS CASE STUDIES

Drug Manufacturer Allegedly Fails To Meet FDA Labeling Standards REGULATORY AFFAIRS Expert Case

This case involves an otherwise healthy 39-year-old woman with a history of trouble conceiving who was told by her physician that taking Vitamin E supplements could increase her chance of conception. The woman purchased a bottle of over-the-counter Vitamin …

FDA Expert Reviews Regulatory Hip Replacement Violations REGULATORY AFFAIRS Expert Case

FDA Expert Reviews Regulatory Hip Replacement Violations

This case involves a hip replacement device MDL. It was alleged that the device manufacturer did not provide proper adverse event reports to the FDA as the data was coming in. An expert in FDA regulations was sought to discuss how the labeling and warning …

Telecommunications Company Misrepresents Speed Of Internet Services REGULATORY AFFAIRS Expert Case

This case is a class action suit that arose from an alleged misrepresentation by the defendant of their high-speed internet and broadband services. It was alleged that the defendants misrepresented crucial information and mislead customers as to what they  …

Competitors Dispute FDA Exclusivity For Generic Drug REGULATORY AFFAIRS Expert Case

Competitors Dispute FDA Exclusivity For Generic Drug

This case involves a Food and Drug Administration (FDA) exclusivity dispute surrounding the development of a generic drug. On the same day, 2 pharmaceutical companies submitted abbreviated new drug applications for the same generic drug. An expert in …

Senior Bank Officers Allegedly Involved In Loan Reporting Scheme REGULATORY AFFAIRS Expert Case

This case involves a bank’s alleged criminal reporting and disclosure of loans. The loans in question were automatically listed as “past due” in some of the bank’s internal tracking systems due to having passed the principal maturity date. However, so …