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FDA Regulations Expert Witnesses

Chemistry and Pharmaceuticals Headshot
E-528687

Chemistry and Pharmaceuticals Expert

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 formulation, stability studies and the management of CROs. He earned his BA ...

Epidemiology, Nursing, and Medical Devices Headshot
E-663217

Epidemiology, Nursing, and Medical Devices Expert

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 in nursing from Evanston Hospital School of Nursing before earning her BS in ...

FDA Regulation of Medical Devices Headshot
E-611415

FDA Regulation of Medical Devices Expert

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 American Society for Quality, and the FDA Alumni Association. Further, he ...

Medical Device Regulations Headshot
E-511302

Medical Device Regulations Expert

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 implementation, and over-the-counter and personal care product development. His former ...

FDA Headshot
E-015772

FDA Expert

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 solutions and training to both small and large companies, and entrepreneurs. ...

FDA Regulations, Congressional oversight Headshot
E-074885

FDA Regulations, Congressional oversight Expert

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 ...

Forensic Legal Analysis Headshot
E-006733

Forensic Legal Analysis Expert

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 legal analysis of companies' Quality Management Systems (ISO 9001), ...

Pharmaceutical and FDA Regulations Headshot
E-007167

Pharmaceutical and FDA Regulations Expert

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 verification of New Drug Applications and Abbreviated New Drug ...

FDA Regulatory Affairs Headshot
E-056391

FDA Regulatory Affairs Expert

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 ...

FDA Regulation and Compliance Headshot
E-065690

FDA Regulation and Compliance Expert

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 ...

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FDA Regulations Related Blog Posts

JUUL Investors Hit with Shareholder Lawsuit

JUUL Investors Hit with Shareholder Lawsuit

Oct 15 2020
There appears to be no slowing down for litigation surrounding JUUL, the electronic cigarette company named in a flurry of lawsuits in the past few years. Most recently, a derivate shareholder lawsuit was filed against Altria Group, a major investor…

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