FDA Regulations Expert Witnesses

ID: 12766

This highly-qualified expert has decades of experience working in medical device regulation and compliance. He earned a BS in chemistry as well as metallurgical engineering from the University of Notre Dame, an MS in regulatory affairs at Northeastern University, and an MBA in international business at Indiana University. He is a certified quality biomedical auditor and a certified medical device...

E-006733

Georgia

This expert's professional career has spanned 50 years, while for the past 20 years he has specialized in guiding companies through the CE marking process for products prepared to enter the EU market and for companies in the US who want CE marking on their products for market flexibility and/or liability protection, many of which are medical devices and machinery. This expert conducts forensic...

ID: 14023

New York

This qualified expert has over 20 of experience years in the field of medical devices with an expertise in injectable drug technologies. Throughout his career, this expert has been employed by and consulted with multiple medical device and pharmaceutical companies and has gained significant experience in technological analysis, medical device engineering and manufacturing, product compliance, and...

E-611415

Illinois

This highly qualified expert has more than 25 years of experience in FDA regulation of medical devices, encompassing nearly all FDA field positions. He earned his BA in biological sciences at California State University and completed MBA courses with Golden Gate University. This expert is certified in regulatory affairs and is an active member of the Regulatory Affairs Professionals Society, the...

ID: 164889

California

Prof. Robin Feldman has 32 years of experience in the fields of Intellectual Property, Health, and Medicine. She earned her BA in International Relations from Stanford University and her JD from Stanford Law School. Formerly, this expert served as a Law Clerk at the United States Court of Appeals for the Ninth Circuit. Currently, she serves as the Director of the Center for Innovation, as an...

E-528687

Rhode Island

This highly-qualified expert in chemistry and pharmaceuticals has 20 years of experience in his field. He has experience with analytical chemistry analysis, formulation chemistry, and FDA regulation, and his work has involved in all aspects of drug research and development from synthesis/purification, in-vitro, in-vivo (efficacy, pharmacokinetics and pharmacodynamics) testing, dosing routs, drug...

ID: 192164

Maryland

Dr. Jonathan P. Jarow has 43 years of experience in the field of Urology and Healthcare with expertise in the Food and Drugs Administration. He earned his BMS from Northwestern University and MD from Northwestern University Feinberg School of Medicine. After completing his residency in General Surgery and Urology at Johns Hopkins Hospital, he went on to complete fellowships in Urology at 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: 19708

North Carolina

This expert has over 20 years of experience in pharmaceutical regulation and compliance. He earned his BA from Harvard College and his JD from Harvard Law School. His areas of expertise involve the regulation, compliance, governance, and enforcement of the pharmaceutical industry, including discovery, development, manufacturing, marketing, and sales. He previously served as a trial attorney for...

E-074885

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...

ID: 1992589

Florida

Dr. Amy Egan has over 15 years of experience in FDA Drug Safety and Regulatory Oversight. She earned her BS in Biology from Santa Clara University, her MD from Loyola University Stritch School of Medicine, and her MPH from Johns Hopkins Bloomberg School of Public Health. She completed her internship and residency in Internal Medicine at Evanston Northwestern Healthcare. Today, this expert is...

E-015772

Texas

This expert has successfully aided many national and international medical device companies with on-site help during FDA audits, FDA-483 responses, Warning Letter Responses, Consent Decree Corrections, ISO audits and readiness, developing and implementing compliant quality systems. She is a former FDA Regional Medical Device Expert and currently provides personalized, FDA regulatory and quality...

ID: 21232

Arizona

This expert earned his BA in business law from Arizona State University. After graduation, he started and ran his own successful vape company for several years. In 2018, his local company was bought by a large national vape company, where he currently works as the Director of Arizona Operations.

E-511302

Pennsylvania

This highly qualified expert has over 40 years of experience in medical device regulations. He received his BS in chemical engineering from Lowell Technological Institute and earned his MS in chemical engineering from the University of Iowa. He currently has 5 patents. Over the years, his work has included antimicrobial development and application, hydrophilic coating development and...

ID: 26037

This highly qualified pharmaceutical safety expert earned his BS in biochemistry and molecular biology at the University of Maryland before beginning his impressive career as a pharmaceutical scientist. He formerly worked as a research scientist at Alpharma Inc, as an associate research scientist at Purdue Pharma, and as a staff scientist at Covance Laboratories. He went on to become a research...

E-663217

Maryland

This highly-qualified expert has nearly 30 years of experience as an epidemiologist and nurse-midwife, with demonstrated experience in medical device safety including gynecologic surgical mesh, breast implants, hip replacement, cardiovascular and dermatologic devices, post-market surveillance, and pharmacoepidemiology. She received her BS in biology from the University of Illinois and a diploma...

ID: 33241

New Jersey

This expert has over 30 years of experience in family and addiction medicine. After gaining his BS in pharmacy at Temple University School of Pharmacy, his degree in osteopathic medicine at the Philadelphia College of Osteopathic Medicine, and completing his residency in family practice at Underwood Memorial Hospital, he served as a staff physician in family practice at numerous northeastern...

ID: 398222

Virginia

Dr. Aloka Srinivasan has 31 years of experience in Pharmaceuticals and Drug Safety. She earned her BS in Chemistry from Presidency University, her MS in Chemistry from the University of Calcutta, and her Ph.D. in Organic Chemistry from the University of Missouri-Columbia. Formerly, this expert served as a Team Leader at the U.S. Food and Drug Administration, as a Principal Consultant at Parexel,...

ID: 41408

New York

This highly-qualified expert has over 30 years of experience as a market analyst and consultant specializing in the coffee industry. She earned her BS in marketing and management at SUNY Albany and is an active member and past president of the Internation Women's Coffee Alliance. In addition, she is a member of the Specialty Coffee Association of America and the ICE Research Program. This expert...

ID: 43541

This expert has over 20 years of experience in the consumer brand industry. He earned his BS in marketing from Michigan State University and his MBA in marketing and strategy at the University of Pittsburgh. This expert has held multiple leadership roles at various food and beverage companies leading them to strategic scale. Formerly, he has served as a manager at Tetra Park, brand director at...