Compliance 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 Compliance Expert Witnesses
What is the role of a compliance expert witness in legal proceedings?
A compliance expert witness provides insight into industry standards, regulations, and best practices. They can testify on whether a party has adhered to these standards or violated them.
In what types of cases might I need a compliance expert witness?
Compliance expert witnesses are often needed in cases involving regulatory violations, corporate governance issues, financial disputes, healthcare compliance, and more.
Can a compliance expert witness help with cases related to data privacy and cybersecurity?
Yes, many compliance experts specialize in areas like data privacy and cybersecurity. They can provide valuable insights into whether proper protocols were followed.
What qualifications should I look for in a compliance expert witness?
Look for an expert with extensive experience in the relevant industry, knowledge of applicable laws and regulations, and ideally prior experience as an expert witness.
Are there subspecialties within the field of compliance that an expert witness may focus on?
Yes, compliance is a broad field with many subspecialties such as healthcare compliance, financial services compliance, environmental regulation compliance, etc.
How does Expert Institute select its Compliance 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.