FDA Regulatory Statistician Experienced in all phases of Clinical Trial Design, Analysis, and BiostatisticsBiostatistics: Regulation of drugs, drug devices and biologics.Clinical and preclinical study design and data analysis, methodological research in statistics, and computer program validation.Expert regulatory statistician (FDA designation).Areas of application include clinical trial design and analysis, interim analyses, multiple imputation, pharmacokinetics, bioavailability and bioequivalence, chemistry and manufacturing controls, stability studies (including bracketing and matrixing), animal safety studies, and carcinogenicity stud...

Biotechnology Expert with Extensive Domestic and International Product and Process Development Experience in Pharmaceutical, Biofuel, Chemical, Agricultural and Nutraceutical IndustriesConducting and directing product, process and manufacturing development activities for biologically-derived materials used in the pharmaceutical, biofuel, chemical, agricultural and nutraceutical industries.Production of biosimilars, monoclonal antibodies and industrial recombinant proteins. Activities include research, development, production, biocomparability, technology management in CMOs, FTO landscape critical for biosimilars, licensing, business deve...

Forensic Toxicology Expert with Considerable Experience with Criminal Cause of Death Investigations and Impairment Related to Alcohol, Pharmaceuticals, and Drugs AbuseToxicologist with forensic board certifications in medicine and forensic examinations.Toxic exposure investigations, including analytical protocol, referral of autopsy material for analyses, environmental and occupational health risk assessments and site assessment and causation determination.Toxic tort defense or plaintiff evaluations, reports, affidavits and expert testimony.Chemical causation assessments with written reports based upon scientific, peer-reviewed methodology...

Over 30 Years of Experience in Pharmaceutical Research and Development. Expert Support in Clinical Pharmacology, Toxicology, Drug Development, Regulatory Affairs and Clinical Research at Major Pharmaceutical CompaniesOver 30 years' experience in pharmaceutical research and development.Clinical pharmacology, toxicology, drug development, regulatory affairs and clinical research at major pharmaceutical companies.Led the research teams that discovered and developed misoprostol (Cytotec®), a worldwide anti-ulcer drugWorldwide clinical research at major pharmaceutical companies.Educator: Pharmacology and toxicology to medical, dental and p...

Occupational and Industrial Toxicology Expert: Program Development, R&D and Product Safety Working in the Biotechnology, Medical Device and Pharmaceutical IndustriesOccupational and industrial toxicology, development programs (both preclinical and clinical) and study design.Conduct and reporting, in evaluating clinical and product safety data, in training and managing staff; in dealing with a wide range of U.S. and foreign regulatory bodies.Addressing commercial concerns, and contract research organizations in labeling and other FDA compliance issues for drugs, devices and dietary supplements.Identifying, developing and implementing new...

Board Certified Toxicologist: Pharmaceutical, Nutraceutical and Consumer Healthcare ProductsFocused toxicity investigations in the consumer health, nutrition pharmaceutical and product safety industries.Drug and food ingredient preclinical development, (all phases) and healthcare products (OTC and personal care products).Product safety and product regulatory consultant frequently interacting with FDA, EPA, international regulatory agencies, U.S. and foreign pharmaceutical and chemical companies.Risk assessments and management of preclinical development and regulatory programs for pharmaceutical, nutraceutical, consumer healthcare, and ch...

Executive Pharmaceutical Research Physician (MD, PhD) Consultant experienced in Clinical Research (Phase 2-4), Regulatory Affairs (inc. filings), Program Strategy Development, Medical Affairs, Advertising and Promotion, Medical Education, Life-Cycle Management and Launch Activities.Review of digital and non-digital Advertising and Promotion materials for existing brands, as well as new product launches, (U.S. and international) press releases, educational materials, sales rep training, OPDP, (Office of Prescription Drug Promotion) regulations.Life-cycle management and new product launch activities, including:Advisory boards, KOL developmen...

Ph.D. Food Science Consultant with Expertise in Food Products, Food Poisoning, and Food Regulatory IssuesFood Science and TechnologyFood SafetyFood PoisoningNatural Ingredient ClaimsFermentationAntimicrobialsProbioticsBotulismAnthraxSporesSpoilageListeria monocytogenesExpert Witness ExperienceConsultant and Expert Witness, various major food companies and law firmsNatural Ingredient Claims - furnished opinions in eight cases as defendant's expert for major food companies affirming that food ingredients such as citric acid, high fructose corn syrup, gelatin, xanthan gum, etc. are natural.Intellectual Property - provided opinion and testifie...

Veterinary Pharmacology and Pharmacokinetics, Bibliographic Assistance, Tissue Residues and Product RegistrationPharmacokinetics in domestic animals.Tissue residues of veterinary drugs.Milk residues of veterinary drugs.Pharmaco-toxicological monographs for veterinary drugs.Registration and development of veterinary pharmaceuticals.Expert-Pharmaceutical RegistrationTechnical support for the development and registration of more than 200 pharmaceutical products for veterinary use in Argentina and Latin America.Independent Consultant...

Toxicologist Consultant and Expert Witness with Worldwide ExperiencePracticing toxicologist of over 20 years providing testimony to governmental agencies, service as an industrial site crisis team member, media (BBC) consultant and services as an expert witness in the United States, United Kingdom and Hong Kong in the following areas: Chemicals Accidents: Chemical and chemical exposures Pesticides and biocides Toxicology Risk Assessment: Drug toxicology and drug testing Building fires and resulting combustion products Chemical fires and explosions Plastics fires and plastic combustion by products Effects/Reactions: Drug...