Pharmaceutical Regulation Expert Witness Listings

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

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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...

David B Ross, MD, PhD, MBI

Clarksville, Maryland
Pharmaceutical Regulation Expert Witness - Food and Drug Administration, Drug/Biologics Safety, Drug/Biologics Adverse Events, Drug/Biologics Labeling, Post-marketing Surveillance, Clinical Trials, FDA Regulations/Procedures, Investigational New Drug Applications(IND), New Drug Applications(NDA), Biologics Licensing Applications(BLA), GMPs, Compliance
I provide consulting services on legal issues in drug safety and efficacy. Specific focus areas include examining the adequacy of product labeling to inform health care providers and patients about the benefits and risks of drugs, biologics, and other FDA-regulated products, as well as the accuracy and completeness of information provided by pharmaceutical manufacturers to investors and securities regulators. My experience includes provision of expert input and support for research into the merits of an action, drafting of court filings, preparation of responses to opposing party filings, and conducting discovery. I have experience in preparing expert witness reports, depositions, and trial testimony. My professional background includes serving for 10 years with the FDA’s Center of Drug Evaluation and Review as a medical officer, senior medical reviewer, medical team leader, and drug review office management official. ➢ Ten years (1996-2006) at FDA Center for Drug Evalua...

Joshua Sharlin, PhD Sharlin Consulting

Stevensville, Maryland
Pharmaceutical Regulation Expert Witness, Medical Devices Expert Witness - FDA, FDA Compliance, FDA Regulations, FDA Software, FDA Drug Safety, FDA Warnings, FDA Drug Warnings FDA Medical Device Safety, Hip Implant Safety/FDA, Medical Device Safety/FDA, Drug Safety/FDA, Labels/FDA, Biologics Safety FDA, Implant Safety/FDA, 510(k)/FDA, NDA/FDA, IND/FDA
Joshua Sharlin applies his knowledge of science (PhD in physiology), insight about FDA compliance and regulatory affairs (former FDA reviewer), and statistical and data management experience to find errors and non-compliant activity committed by FDA-regulated companies and their outsourcing partners. He has testified and been deposed in cases about drugs and medical devices. Dr. Sharlin is skilled in analyzing technical and regulatory information to answer three questions: What did the company know and when did they know it? What should the company have known and when should they have known it? What should the company have done and when should they have done it? He is a skilled teacher. Over 50,000 people from hundreds of FDA regulated companies have attended his classes on over 40 technical and regulatory topics.

Paul A. Arpino, PharmD

Newton, Massachusetts
Pharmacist Expert Witness, Pharmaceutical Regulation Expert Witness - Hospital and Ambulatory Pharmacy Practice, Standards of Pharmacy Practice, Medication Errors, Medication Safety, Adverse Drug Reactions, Drug Interactions, Standard of Care, Anticoagulation, Pharmacy Standards, Therapeutic Drug Monitoring, Pharmacy regulations
Extensive knowledge in pharmacy practice, regulatory compliance, medication management and standards of pharmacy practice across a variety of patient care settings. Board Certification in Pharmacotherapy (BCPS). Available as a consultant for both plaintiff and defense cases.

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 Pharmaceutical Regulation Expert Witnesses in:
Massachusetts, North Carolina, Florida, and Maryland