Environmental Chemistry Consultants: 2

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

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