Zantac Expert Witnesses in Connecticut
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FDA Regulations Expert Witness
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 Management Team (SVP RA) for three small companies developing novel drugs and biologics, and building and leading a product compliance organization (RA, QA and CQA) for a small biotech company, including approval of their first monoclonal antibody product, while serving in a leadership role on the Management Team. Prior to that, have led regulatory activities for several NDAs (leading to marketed products), INDs and post-marketing regulatory activities in 3 large pharmaceutical companies. She has 5 years experience in small molecule API process development and a PhD in medicinal chemistry and is a frequent contributor to various Industry programs. Specialties: All aspects of Regulatory Affairs for entire product lifecycles for small molecules and biologics, including: -IND/NDA/BLA submission management, prosecution and strategy -FDA meetings -Regulatory Liaison activities -Ad/Promo review and advising -CMC
Principal, A Pharmaceutical Regulatory Affairs Compliance Firm
Doctor of Philosophy (PhD), University of Rhode Island
Waterford |
Connecticut
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FAQs for Zantac Expert Witnesses
What is the role of a Zantac expert witness in legal proceedings?
A Zantac expert witness provides specialized knowledge about the drug, its effects, and potential side effects. They can testify on matters related to pharmaceuticals, toxicology, and pharmacology.
What types of cases might require a Zantac expert witness?
Cases involving allegations of harm from Zantac use, such as cancer or other health issues, often require the expertise of a Zantac expert witness.
Can a Zantac expert witness provide insight into the drug's recall?
Yes, a Zantac expert witness can provide detailed information about the reasons behind the drug's recall and its implications for users' health.
How can a Zantac expert witness help in cases involving alleged failure to warn?
The expert can evaluate whether adequate warnings were provided about potential risks associated with Zantac, based on industry standards and regulations.
Are there subspecialties within the field of Zantac expert witnesses?
Yes, some experts may specialize in areas like pharmaceutical manufacturing, oncology (cancer), gastroenterology (digestive system), or regulatory affairs.
How does Expert Institute select its Zantac expert witnesses?
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.