Pharmaceutical Regulation Expert Witnesses

The SEAK Expert Witness Directory contains a comprehensive list of pharmaceutical regulation expert witnesses who testify, consult and provide litigation support on pharmaceutical regulation and related issues. Pharmaceutical regulation expert witnesses and consultants on this page may form expert opinions, draft expert witness reports, and provide expert witness testimony at deposition and trial. The issues and subjects these pharmaceutical regulation expert witnesses testify regarding may include: Compliance, Drug Development, FDA, Medical Devices, Accreditation, Adverse Drug Reactions, Adverse Experiences, Antibiotics, Anticoagulation, Biochemistry, Biologics Safety Fda, Board Of Pharmacy Relations, C. Difficile, Chemical Synthesis, and Chemistry.

Use the search box above to further refine your search for pharmaceutical regulation expert witnesses by keyword and state. Attorneys contact the experts directly – with no middleman.

Dennis K McAllister, R.PH, FASHP McAllisteRx Consulting LLC

Phoenix, Arizona
Pharmacist, Pharmaceutical Regulation - Pharmacy standard of care/negligence, Board of Pharmacy relations, national pharmacy regulatory affairs, hospital pharmacy, community pharmacy, mail service, non-resident pharmacy issues, pharmacy technology regulations, and automation issues.
Dennis is an Arizona-based pharmacist with a broad set of practice experiences acquired over 40 years of pharmacy practice. He served in the United States Air Force as a pharmacy officer, and opened and operated a community pharmacy after leaving active duty. Dennis has served as Director of Pharmacy at three hospitals, two in rural areas, and the other, an 800-bed facility with an attached children’s hospital in an urban setting. Dennis was a founding faculty member at the Midwestern University College of Pharmacy-Glendale, eventually serving as its Assistant Dean. As the Pharmacist in Charge of the Humana Mail Pharmacy in Phoenix, managing pharmacy practice for a staff of 700 that filled over 35,000 prescriptions each day. Dennis has worked for the last decade as the Senior Director of Pharmacy Regulatory Affairs for Express Scripts, supervising a team that covered all 50 state boards. He recently retired from that position. Dennis has extensive experience in standard of care an...

Willa L Carter CQG

Conyers, Georgia
Chemistry & Chemicals, Pharmaceutical Regulation - Medical devices, pharmaceutical research, patents, drug formulation, quality control, laboratories, manufacturing, drug packaging, cosmetics, food, ISO, International Standards of Harmonization (ISO), environmental conditions, compliance, sterilization, chemical synthesis, fermentation, components
Experienced Chemist with 25+ years of experience in quality control, raw materials, manufacturing, validation, and stability. Experience in pharmaceutical, medical device, cosmetics, and food industries. Former odor panel scientist at Proctor & Gamble as a contractor. Extensive teaching experience. International inspector.

Tim Kamerzell, MD, PhD

Overland Park, Kansas
Hospitalist, Internal Medicine - Hospital Medicine, General Internal Medicine, Telemedicine, Perioperative Medicine, Medical Devices, Pharmaceutical Research and Development, Pharmaceutical Regulation, Chemistry, Biochemistry,
Tim Kamerzell, MD, PhD is a board-certified Internal Medicine physician. He is an active Hospitalist and general practice primary care physician at HCA Midwest Health in Overland Park, KS. Dr. Kamerzell received his residency training in Internal Medicine at Washington University in St. Louis and The University of Kansas School of Medicine. He is a core faculty member of the Internal Medicine residency program at HCA Midwest Health and was previously the Associate Program Director of Internal Medicine. He currently serves in various leadership roles including the Vice Chair of the Department of Medicine for Overland Park Regional Medical Center, Physician Advisory Board Member and Facility Lead Physician for the Overland Park Market of HCA Healthcare, Inc. Dr. Kamerzell received a PhD in Pharmaceutical Chemistry from the University of Kansas and has extensive experience working in the pharmaceutical industry as a research scientist at Genentech, Inc. Dr. Kamerzell completed researc...

David B Ross, MD, PhD, MBI

Baltimore, Maryland
Pharmaceutical Regulation, Infectious Diseases - Food and Drug Administration (FDA), drug/biologics safety/labeling/post-marketing surveillance, FDA drug/biologics regulations/procedures/applications (INDs/NDAs/BLAs), clinical trials, drug development, pharmacy compounding, HIV, MRSA, antibiotics, hepatitis, osteomyelitis, influenza, C. difficile
Dr. Ross is a Yale fellowship-trained, board-certified infectious disease physician. An active clinician in practice for over 25 years, he provides patient care in the areas of infectious disease and primary care. Dr. Ross holds a medical degree from New York University School of Medicine, and an undergraduate degree in Molecular Biophysics and Biochemistry from Yale University. He completed his internal medicine residency training at NYU Medical Center, and infectious disease fellowship training at Yale University. Dr. Ross also holds a M.S. and Ph.D. in Biochemistry from NYU, and a Master’s Degree in Biomedical Informatics from Oregon Health and Sciences University. Dr. Ross spent 10 years with the FDA’s Center of Drug Evaluation and Review (CDER) as a medical officer, senior medical reviewer, medical team leader, and new drug review office management official. He has extremely broad experience with FDA regulatory submissions (INDs, NDAs, BLAs, post-marketing safety, labeling ...

Joshua Sharlin, PhD SHARLIN CONSULTING

STEVENSVILLE, Maryland
Pharmaceutical Regulation, Medical Devices - FDA, FDA Compliance, FDA Regulations, FDA MAUDE, FDA Drug Safety, FDA Warnings, FDA Drug Warnings, FDA Medical Device, FDA law, FDA regulatory, Drug Safety/FDA, FDA Medical Devices, Biologics Safety FDA, Implant Safety/FDA, Medical device product liability
Worked as an FDA regulatory expert witness in over 50 cases, deposed 16 times and testified 5 times. Based on experience training over 40,000 staff at FDA-regulated companies on technical and regulatory topics, skilled in explaining FDA related topics to juries. Broad and deep skills in drug, biologic and medical device development. Hands-on experience in the entire lifecycle of product development from initial regulatory strategy, clinical trial planning and execution, to submission preparation and review at FDA. Authority in the collection, statistical analysis, interpretation, and presentation of information to FDA. Expert in understanding FDA reviewer’s actions and reactions. Specialist in analyzing FDA compliance information to answer three questions: 1) What did the company know and when did they know it? 2) What should the company have known and when should they have known it? 3) What should the company have done and when should they have done it? Provide FDA related ...

Paul A. Arpino, PharmD

Newton, Massachusetts
Pharmacist, Pharmaceutical Regulation - Hospital, Outpatient Retail Pharmacy Practice, Standards of Pharmacy Practice, Medication Errors, Medication Safety, Adverse Drug Reactions, Drug Interactions, Standard of Care, Anticoagulation, Controlled Substances, 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.

Debra Leibold, MD, PhD Consultant

Blue Bell, Pennsylvania
Pharmaceutical Regulation, Warnings & Labels - Pharmaceutical Industry, Drug Development, Product Labeling, Regulatory Labeling, Prescribing Information, Indications, Dosage, Contraindications, Warnings, Precautions, Adverse Experiences, Regulatory Compliance, Safety, FDA, Off-label Use
Ethical Full Lifecycle Labeling/Prescribing Information That Never Cuts Corners For Pharmaceutical Giants Merck, Shire, and J&J: Labeling strategy and leadership that brings product labeling and products to market supporting vaccines and treatments for infections, internal medicine, oncologic, and rare diseases. These include life-saving, ground breaking, and first-of-its-kind products. Bring decision makers across divisions to the table to negotiate resolution of labeling issues - leading to the creation, revision, and maintenance of clear and compliant product labels that educate health care professionals and patients in the US, EU, Japan, and Rest of World. Gain consensus and champion proactive consensus-building across Research, Statistics, Regulatory, Joint Ventures, Legal, and Marketing on labeling - laser-focused on the bottom line: “What do the doctor and patient need to know?” Provide leadership in support of label development for new applications, supplemental appl...

Kathleen L Jackson, R.Ph., Ph.D. (H.C.), FIACP Jackson Audit and Compliance

Alvin, Texas
Pharmacist, Pharmaceutical Regulation - USP <797> <795> <800>, Sterile and non-sterile compounding, FDA 503(a) and (b), State Inspections, Accreditation, Compliance, Critical Point Training, NABP, PCAB, Inspections, FDA Drug Compliance Expert
Kathleen Jackson is a licensed and experienced 40+ year pharmacist with specialized training and experience in compounding and compliance with regulations. She owned and operated a community pharmacy with an emphasis on compounding for 22 years. She has most recently received an NABP Inspector Certification (CISCI) in November 2018, expiring June 2023. Kathleen was also previously accepted by FDA to monitor a pharmacy as a Drug Compliance Expert. She has presented at several PCCA International Seminars as well as local community clubs and organizations. Kathleen was awarded "Pharmacist of the Month" in March 2002 by PCCA (Professional Compounding Centers of America). She has performed inspections and prepared reports to Boards of Pharmacy related to license suspensions/probation orders. Kathleen has co-authored two articles on Root Cause Analysis in the IJPC (International Journal of Pharmaceutical Compounding). She has also authored several articles in the Texas Pharmacy magaz...
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