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FDA Regulations, GMP/GLP/GCP Compliance; IND, NDA, BLA, PMA and Product Regulation; Toxicology
Experienced in all aspects of validation and compliance including, GMP/GLP/GCP and part 11. Expert worked for over five years as a reviewer of investigational new drug applications, marketing applications, developing guidance and government policy and supporting approval process. In addition,…
Toxicology, Environmental Health and Safety, OSHA Regulatory, Mold, Healthcare and Laboratory Safety
Expert's experience is very broad in the areas of chemicals effects on humans and environmental systems. He has performed academic research on the effects of hazardous chemicals on the lungs, as well as carcinogenic effects of chemicals and air pollutants,…
Toxicology, Cyanide, Toxic Metals, Environmental Health, Risk Assessment
Expert MD is a physician specializing in the evaluation and treatment of patients who have developed injuries or illness as a result of chemical, physical or biological agents. She is Board Certified in: Toxicology – through the American Board of…
Trace Detection, Ion Mobility Spectrometry (IMS), Forensic Analysis of Narcotics, Explosives, etc.
Expert has been involved in analytical chemistry since before college graduation. He has 5 years of clinical chemistry, 15 years of forensic chemistry focusing on toxicology and narcotic identification. Expert has 25 years of hands-on experience with a wide variety…
Scientific Fraud; the Organization and Management of Business Operations
Expert has established a clear record of finding key management and organization problems in manufacturing, hospital operations and the research and development of DNA diagnostics. Since 1976, the expert has uncovered and addressed significant organization problems in small and large…
Pediatrics and Pediatric Emergency Medicine
Over two decades experience in academic and clinical pediatrics. General pediatrics, Pediatric Emergency medicine, Outpatient and Primary Care Pediatrics; Pediatric Trauma; Expert has identified the following as a detailed list of expertise, specialties and interests in the medical field of…
Medical/Surgical Device Design, Management, Marketing, Regulatory
Expert is a results-oriented professional with proven domestic and international experience in health care administration, medical devices, marketing, staff development, product development and management, luminary and customer liaison, public relations, technology assessment and transfer, intellectual property, research and development, clinical…
Patent Law, Law, Medical Device Design, Drug & Perishable Material Stability, 510(k) Approvals
Expert's legal practice focuses on intellectual property and patents. He is registered to practice both in California for general legal issues, and nationally for patent issues through the USPTO. In addition to filing and prosecuting patents, he also has experience…
Pharmaceutical Manufacturing, Research and Development, Education & Training
Expert’s primary experience in tablet manufacturing covered conventional pharmaceutical tablets for a variety of drugs and chewable tablets of antibiotics, utilizing both dry and wet granulation techniques and a variety of processing and tablet equipment. His experience encompasses all aspects…
Molecular Oncology, Cervical Cancer, Breast Cancer, Immunohistochemistry, Diagnostics, and Pathology
Expert trained as a classical molecular biologist using viral model systems to examine regulation of gene expression and DNA replication in bacterial and animal viruses. His post-doctoral work focused upon regulation and malignant transformation caused by human papovaviruses and adenoviruses.…