Timothy A. Anderson, MS, MBA, is a former FDA Review Chemist, with over 35 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 23 years, Mr. Anderson has furnished clients with services ranging from providing regulatory application filing strategies specialized in Chemistry and Manufacturing Controls, 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
Litigation Support - Mr. Anderson has been deposed, testified in Federal Court, and functioned as a Subject Matter Expert Witness and consultant to litigation in the Pharmaceutical, Biologic, and Device Life Sciences space, focused in areas of Anti-trust, Patent, and Product Liability.
Joseph H. Guth, PhD, CIH, has in-depth expertise in many fields of Toxic and Hazard Assessment, as well as a very broad background in both academia and industry. A Chemist and Biochemist, he is the President and Principal expert of Scientific and Forensic Services, Inc.
Background Experience - Having a broad range of in-depth experience in numerous fields of science, Dr. Guth has owned and operated several testing and R&D laboratories over a 50 year period, including nationally-known Interscience Research Inc. In basic and applied research, university teaching and finally as Laboratory Director, his scientific expertise was developed first-hand in the many specialties that his laboratories were called upon to perform.
Litigation Support - Dr. Guth has offered his independent expertise in 100s of civil and criminal cases since 1979. He has also been a consultant and peer reviewer for EPA and NIOSH. He currently specializes in Toxic Torts and related matters both inside and outside of the workplace. He has numerous regular nationwide clients in the legal profession and the insurance industry.
Attorneys throughout the U.S. have found Dr. Guth's ability to examine, test and evaluate their cases and the evidence to be invaluable. If desired he can provide multifaceted support for many kinds of cases. Examples of his broad expertise also involve such issues as Standards of Industry, state-of-the-art, duty-to-warn, warning labeling and applicable governmental regulations.
Services - Consulting, retrospective hazardous exposure assessments, site inspections and sampling, some testing and examination services, reports, research & development, and court testimony.
Areas of Expertise:
CHEMISTRY - Analytical, Environmental, Inorganic, Metallurgical, Organic, Polymer, Biochemistry, Forensic, Atmospheric and Compressed Gases, Nuclear Chemistry, Food and Pharmaceutical Analysis; Water Testing, Industrial Process Troubleshooting
INDUSTRIAL HYGIENE - Comprehensive Practice, OSHA Compliance, Toxicology, Carcinogen Exposure, Hazardous Exposure Risk Assessment, Exposure Modeling, Asbestos Issues, Lead Poisoning Issues, Pesticide Poisoning, Solvent Exposure, Indoor Air Quality Evaluation, Microbiology, Mold, Physical Stressors, Radiation Exposures, Safety Assessment, Material Safety Data Sheet Development
MATERIAL SCIENCE - Properties and Strength of Various Materials, such as Metals, Plastics and Other Polymers, Glass, Textiles, Masonry, Construction Materials; Failure Mechanisms of Materials, Product Designs and Safety
OTHER FIELDS - Labeling and Duty to Warn Issues, Quality Assurance Program Evaluations, Environmental Impact, Industry Standards, State-of-the-Art Issues, Governmental Regulatory Issues, U.S. Environmental Protection Agency Requirements, U.S. Consumer Products Safety Commission Issues, U.S. Food and Drug Administration Issues
For those of you not dealing with much product liability or personal injury case work, you may not have noticed some newer up ticks and trend lines. For others who have been too focused on one area of this specialized litigation, this note will add to your awareness of things to come.
Water and molds have been here much longer than Man. We utilize some, coexist with others, and battle many more of them. Molds help us make cheese, produce penicillin and other useful medicines; but they can also harm us. It is the latter problem that requires a better response from the medical community
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)
American Association of Pharmaceutical Scientists
British Toxicology Society
Society of Toxicology
Editorial Boards of Inhalation Toxicology and Journal of Fire Sciences