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...
Specialties:
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...
Specialties:
A Regulatory Affairs expert witness provides insight and testimony on matters related to regulatory compliance, product approval processes, and industry standards in various sectors.
These experts are crucial in cases involving pharmaceuticals, medical devices, food safety, environmental regulations, and any sector where regulatory compliance is key.
They can provide insights into FDA approval processes, drug safety regulations, labeling requirements, and other aspects of pharmaceutical regulatory affairs.
Yes, some experts may specialize in specific areas like pharmaceuticals, medical devices, biotechnology, or environmental regulations depending on their experience.
Industry-specific knowledge ensures the expert is familiar with the unique regulatory landscape of that sector, providing accurate and relevant testimony.
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.