Pharmacy / Pharmacology / Pharmaceuticals Consultants: 5

Timothy A. Anderson, MS, MBA, is a former FDA Review Chemist, with over 43 years of career experience in Pharmaceutical R&D, Quality Operations, and Regulatory Affairs. A uniquely interdisciplined individual, he melds comprehensive pharmaceutical industrial R&D, business development, QA/QC, and consultancy experiences with formal FDA-tenured regulatory credentials. 

As a consultant in his own pharmaceutical development advisory firm for over 29 years, Mr. Anderson has furnished clients with services ranging from providing regulatory application filing strategies specialized in Chemistry and Manufacturing Controls (CMC), to current Good Manufacturing Practice (cGMP), quality system regulation (QSR) audits for finished dosage, and active pharmaceutical ingredient (API) manufacturing, as well as for device, drug-device combination, and biologic products.  Technical and regulatory compliance due diligence services are furnished to institutional investors.  

Mr. Anderson has contributed to regulatory approvals for over 50 drug and drug / device applications, spanning generic (ANDA) and innovator NDA, BLA, 510(k), PMA, and 505(b)(2) applications, and has provided regulatory compliance remediation services to resolve Form 483, Warning Letter, and Consent Decree issues. 

Clients have included Medtronic Ave., Allergan, Memorial Sloan-Kettering Cancer Center, Mass Biologics, MDS Pharma, US Pharmacopieia, Boehringer Ingelheim, BristolMyers Squibb, Genzyme, Intelliject/Sanofi, Church & Dwight, CR Bard/Davol, Ximedica, Fresenius-Kabi (Austria), KRS Biotechnology Ajanta, and many more

Consulting Services: 

Global Regulatory Filing Review / Writing Agency Negotiation Strategic Advisories

Contracted Management Services Current Good Manufacturing Practices Compliance Quality Systems

View Timothy Anderson's Expert Witness Profile.

Ted W. Simon, PhD, DABT, is an award winning Environmental Toxicologist and Scientist. His expertise is in toxicology, risk assessment, mathematical modeling, statistics, neuroscience, and environmental / ecological health issues.

Dr. Simon has over 10 years of experience as a toxicologist employed by the Environmental Protection Agency (EPA). He served as EPA’s senior toxicologist in the waste management division working on risk and soil cleanup.

Teaching Experience - Since 2001, Dr. Simon has served as an Instructor / Adjunct Professor in the Department of Environmental Health Science, College of Public Health, at the University of Georgia.

Public Speaker - Well published, including the author of a textbook on toxicology and environmental risk assessment, Dr. Simon has extensive national and international public speaking experience. Since 1996, he has been delivering seminars and lectures to universities and national institutes on many subjects within his area of expertise. In 2016, he delivered a lectures on “Bayesian Methods for Application of Uncertainty Factors,” to the Society of Toxicology Annual Meeting, New Orleans, LA, and “Quantitative Prediction of Phenotypic Change from High Throughput Assay Results,” to the EPA's Workshop on In Vitro to In Vivo Extrapolation, Research Triangle Park, NC.

Litigation Support - Dr. Simon has over 15 years of experience offering expert witness services to counsel representing both plaintiff and defendant. He has been retained over 20 times since 2000 for cases involving environmental risk, drug and alcohol cases, DUI, accidental poisoning, and intellectual property. Dr. Simon has particular expertise in dioxin-like chemicals and polychlorinated biphenyls (PCBs). His services include consulting, reports, deposition, and trial testimony when necessary.

Areas of Expertise:

Dioxins PCBs Drugs Alcohol Poisoning DUI / DWI Water Contamination Soil Contamination Environmental Risk Assessment

Environmental Toxicology Carcinogenicity Food Contamination Pesticides Fracking Lead Marijuana Polychlorinated Biphenyls Intellectual Property

John Budny, PhD, provides expert Toxicology opinions based on recognized and accepted medical knowledge to determine if prescriptions, over-the-counter medications, and drugs of abuse that cause adverse medical events. With a PhD in basic medical science and a 40-year career as a practicing toxicologist, Dr. Budny combines the science of toxicology with medical knowledge to fully understand the ramifications of an adverse medical event caused by prescribing errors, faulty medications, or failure in the health care delivery process.

Dr. Budny has conducted scientific investigations in toxicology and has published the results of his research. In addition to being as an expert witness, Dr. Budny provides scientific contributions by writing book reviews of relevant topics related to toxicology and forensics. He is also on the Editorial Board of the International Journal of Toxicology. In his position on the Editorial Board, Dr. Budny reviews manuscripts on general toxicology and forensic topics that are submitted and proposed for publication in the journal. He also writes book reviews that cover the entire breadth of toxicology. 

Litigation Support - Dr. Budny has over 25 years of experience as an expert witness. He has been retained in over 300 cases in which he has opined in reports, depositions, and in court testimony about cause and effect relationships between chemicals and adverse reactions and toxicities. While his forensic toxicology practice is not limited to any specific type of chemical, most of his retention as an expert has been for prescription drugs, illicit drugs, dietary supplements and nutritional products.  

Successfully resolved complex medical issues involving pharmaceuticals and drugs:

Cardiovascular and Cerebrovascular Toxicology Pharmacology and Physiology Drugs Affecting the Central Nervous System Cognitive and Psychomotor Impairment Pharmacokinetics Dietary Supplements, Nutraceuticals, and Nutrition Opiates Wrongful Death

Antibiotic, Analgesic, and Anesthetic Toxicology Over-the-Counter (OTC) Product Toxicology Amphetamine Toxicity Fentanyl Drugs of Abuse Marijuana Animal and Plant-Derived Toxins

Dr. James C. Norris, Ph.D., DABT, EURT is an Expert Witness in Toxicology and Pharmacology. He has Litigation and Arbitration experience in the United States, United Kingdom and Hong Kong. Dr. Norris has given testimony to government agencies, has acted as a consultant for the media (BBC) and is an Industrial Site Crisis Team Member. He is avaliable for both Plaintiff and Defense.

Areas Of Expertise:

• Carcinogenicity and Chemicals
• Combustion or Fire Toxicolog
• General and Inhalation Toxicology
• Pesticides, and Pharmaceuticals (pharmacology)

Professional Affiliations:

• American Association of Pharmaceutical Scientists
• British Toxicology Society
• Society of Toxicology
• Editorial Boards of Inhalation Toxicology and Journal of Fire Sciences

Wayne H. Grant, PharmD, has been a registered Clinical Pharmacist, in good standing, in the State of Ohio, since 1990. Dr. Grant's current clinical practice targets disease state management in multiple areas, including but not limited to; cardiology, gastrointestinal, geriatrics, nephrology, oncology, psychiatry, and pulmonology. 

Consulting Services - Dr. Grant provides Comprehensive Medication Management services, including a complete review of prescriptions and over-the-counter medications. He is available for direct communication with patients and families. 

Experience - A detailed understanding of pain management is paramount to his current practice. Dosage routes from oral, intravenous, intrathecal, and others, in conjunction with strong opioids and adjuvants, garner much of Dr. Grant’s attention. He has delivered local, state, national and international speaking programs reflective of the fundamental practice of pharmacy. As a peer reviewer for the American Journal of Health-System Pharmacy, Dr. Grant has provided feedback on articles that will determine future drug therapies. A history of clinical practice, management, and education culminates present-day understanding of the pharmacy profession. 

View Dr. Grant's Profile.