N. BHUSHAN MANDAVA, Ph.D. is the Founder and President of Mandava Associates. Dr. Mandava previously held Senior Management Positions at USDA, EPA and SRS International. Dr. Mandava has over 40 years of diversified experience in Pesticide Regulations, Food and Agricultural Chemistry, Plant Biotechnology, Pesticide Active and Inert Ingredients, New Product Development/ Market Analysis, Product, Residue and Environmental Chemistry, Biochemistry, Plant and Animal Physiology and Metabolism, Hazard, Exposure and Risk Assessment, PMN and Other EPA Regulations, FDA Regulations for Food Additives, Drugs, Devices and Diagnostics, Litigation Support for Chemical Torts, Product Liability, Hazardous Wastes, and Right-to-Know Laws, GLP and GMP Audits, Project and Program Management.
Madhu Mandava, B.A. has been with Mandava Associates since 1989. He was formerly with State of Maryland and SRS International. Prior experience in Pesticide and Food Additive Regulations, PMN and other TSCA Filings, Placement and Coordination of Lab Studies, Agency Coordination and Communication, Market Research and Economic Analysis, Pesticide Registrations, Labeling and Compliance Issues, Operations Management, Database Management, Project and Program Management.
Robert P. Barron, B.S. is Former FDA Review Chemist, Center for Drug Evaluation and Research, Division of Oncology Drug Products and Division of Pulmonary Drug Products. Prior to this Dr. Barron was a Research Chemist at the FDA in the Bureau of Biologics, Bureau of Drugs, and Bureau of Foods. Dr. Barron held positions at the DEA as a Forensic Chemist. Dr. Barron provides experience in chemistry, NDAs, supplements, and INDs. Dr. Barron has experience in dealing with FDA guidelines and regulations pertaining to GCP, GLP, GMP, and also with CFR, USP, and ICH and environmental requirements.
Santi K. M. Bhagat, M.D., MPH was formerly with the National Institutes of Health, and Georgetown University and the Children's National Medical Center. Dr. Bhagat has over 12 years of experience in principles, practices and research methodologies applicable to the medical and scientific area of microbiology, anatomic and clinical pathology. Dr. Bhagat received her MPH degree from George Washington University and has over 6 years of experience in health care policy and health care regulatory issues.
Michael G. Farrow, Ph.D. is Former Director of Toxicology, EPL Laboratories; Director of in vitro Program Development, Hazelton Laboratories, Assistant Director of Toxicology, Wyeth Laboratories, SRS International, and is a member of Regulatory Affairs Professional Society. Dr. Farrow's area of expertise is in Genetic and General Toxicology, Laboratory Operations, GLP & QC Auditing, Regulation of Medical Devices, Diagnostics, Biotechnology, Food Additives and Drugs.
Gary Flamm, Ph.D. is the Former Director of Toxicology at FDA. Dr. Flamm has Special Expertise in Toxicology, Biochemistry, Pharmacology, Chemical Safety Evaluation, Human and Animal Physiology and Metabolism, Pharmacokinetics, Risk Assessment, FDA Regulations, Food Additives, Human and Animal Drugs, and Cosmetics.
Robert A. Jerussi, Ph.D. is Former FDA Associate Director for Chemistry, Center for Drug Evaluation and Research. Dr. Jerussi managed chemistry, quality control functions for manufacturing, and QC audit programs for office of generic drugs. Dr. Jerussi provides experience in chemistry and manufacturing controls, auditing drug substance facilities, and reviewing FDA pre-submissions.
Marguerite L. Leng, Ph.D. is Former Product Registration at Dow Chemical Company. Dr. Leng has experience in Regulatory Affairs, Safety Evaluations, Toxicology, Biochemistry, Pesticide Residue and Environmental Fate, Worker Exposure, and Food Safety.
Srinivas Mandava, M.D. was formerly with National Institutes of Health, Pennsylvania State University at the Hershey Medical Center, and the University of Maryland Medical Systems as a senior research/clinical investigator. Dr. Mandava has over 12 years of experience in pharmaceutical & medical devices R&D, FDA regulations for medical devices and pharmaceuticals, implementation of clinical studies, safety monitoring, and audits.
David G. Van Ormer, Ph.D. was formerly with EPA and U.S. Army for over 25 years. Experience in Regulatory Toxicology, Industrial Hygiene, Environmental and Drug Analysis, Structure-Activity Relationship, Risk Assessment, Pesticide and Toxic Chemical Regulations.
Elizabeth K. Weisburger, Ph.D. is the Former Assistant Director with National Cancer Institute. Dr. Weisburger was responsible for establishment of National Toxicology Program at NIH. Her special expertise is in Chemical Carcinogenesis, Carcinogen Evaluation and Toxicological Assessments, Pharmaceuticals, Food Additives, GRAS Evaluations, Carcinogen Bioassays and Environmental Pollutants.
Thomas K. Wong, Ph.D., MPH is the Former Senior Director of Clinical Operations at EMD Pharmaceuticals, Senior Director of Clinical Development of Lexigen Pharmaceuticals Corporation, Director of Clinical Research at SRS International, and Program Director of Medical Studies at Research Triangle Institute (RTI). Dr. Wong has experience in covering infrastructure building, clinical operation, clinical monitoring, product team building, and product development. Dr. Wong's areas of expertise are in therapeutic areas of AIDS, Infectious Disease, Respiratory, Dermatology and Oncology.
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Note: To view our staff's profile, please click on their name and you will be able to view their Curriculum Vitae. These are Adobe Acrobat PDF files. If you do not have Acrobat Reader, you can download it from Adobe.