Labeling Expert Witness Listings

Welcome to our Labeling experts directory. Browse the profiles below to find the right expert witness in Labeling for your case. Our SEAK Expert Witness Database is always free to search.

SEAK, Inc. is The Expert Witness Training Company. We have trained thousands of expert witnesses, through our seminars, on-site corporate training, assisting retaining counsel to prepare their witnesses, and one-on-one training for individual experts. For additional information please visit testifyingtraining.com

Unable to find the right expert? For personalized assistance in locating an expert witness, please click here.

Catherine E Patterson, PhD Biotech Research Group (BRG)

Tampa, Florida
Pharmaceutical Regulation Expert Witness, Warnings & Labels Expert Witness - Pharmaceutical, Drug, Device, Failure to Warn, Labeling, FDA, Regulatory, Product Liability, OTC, Prescription, Safety, Risk
Dr. Patterson has focused on human disease and treatments with attention to both efficacy and safety. Investigations of medical literature, legal files and regulatory documents for medical conditions, drug products and medical devices as well as comparators are the basis of her regulatory opinions. Any pharmacovigilance, device safety reviews, adverse event and labeling analyses use resources such as PubMED, Embase, FAERS, MAUDE, and internal company documents. Her regulatory experience has included 510(k), PMA, pre-IND, IND, NDA, ANDA and 505(b)(2) submissions. Dr. Patterson routinely writes FDA submissions, white papers, clinical study protocols, medical descriptions and labeling. She has additional experience with peer-review publications and grant writing. She is currently the Chief Scientific Officer for Biotech Research Group in Tampa. Her PhD was awarded from Princeton University in Molecular Biology for her work with viruses. In the past she provided scientific re...

Nancy J. Chew, M.S., RAC, FRAPS Regulatory Affairs, North America, Inc.

Durham, North Carolina
Pharmaceutical Regulation Expert Witness - FDA, Food and Drug Administration, 21 U.S.C. and 21 CFR, Investigational New Drug Applications, New Drug Applications, FDA-regulated product development and registration, regulatory affairs practice, FDA regulated industry, submissions/dossiers, labeling, compliance.
Specialty Focus: FDA regulatory requirements, Product development strategy, FDA-regulated product development, FDA regulatory liaison, regulatory submissions, clinical research applications (INDs), drug marketing applications (CTDs, NDAs), FDA approvals, US agent for FDA matters. Education: M.S. Physiology, Florida State University, 1968. B.A. Biology, Woman's College of the University of North Carolina, 1963. Years in Practice: 35+ Additional Information  Certified regulatory affairs expert with over 35 years experience in pharmaceutical regulatory affairs.  Significant teaching experience in the pharmaceutical and regulatory field, and lectures frequently on regulatory matters.  Published in technical journals, magazines, books, articles, and columns in the regulatory and pharmaceutical fields.  Member of the Scientific Advisory Board for BioLink Sciences, Inc.  Holds a regulatory affairs certification and is a fellow of the Regulatory Affairs Professiona...

You can also find Labeling Expert Witnesses in North Carolina and Florida