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Regulatory Affairs, Technology Management, Pharmaceutical Industry, Turnaround Management
Expert has experience in applying 21 CFR Part 11 to the manufacturing of pharmaceuticals and preparing and facing FDA inspections. He has more than 20 years of experience in various facets of API industry ranging from research to manufacturing, projects,…
Spain Drug Market, Drug Reimbursement, Drug Therapy, Generic Drug Market, Biologic Therapy, HIV, Oncology, Hematology
Expert is an hospital pharmacy specialist, with a PhD and Masters in Pharmaceutical Care and Pharmacy Oncology Diplomade from Valencia University, Spain, as well as a Masters in Pharmacovigilance from Sevilla University, Spain. Expert is a clinical pharmacist of the…
Transportation, Safety, Railroad, Bus, Highway, Pedestrian, Passenger, Bicyclist, Workplace, Parking
Expert is a transportation and traffic engineering expert and has served as a litigation consultant since 1997. Because of expert’s 50 years of expertise, he is frequently consulted at the initial stages of a potential litigation for impartial input that…
Pharmaceutical Formulations, Nutraceutical Formulations
Expert is an expert in developing multi-source drug formulations and generic equivalents of innovator products. To date, he has developed and put into the international market more than 100 such products. Consultant to Zim Laboratories Ltd. from 1994 to 2000…
Psychopharmacology in Historical Perspective, Regulatory Behavior, etc.
Over the past 20 years he has done extensive research on the history of drug discovery, drug development, drug registration, and the use of psychopharmaceuticals in medical practice. Among the documents he has collected are the virtually complete set of…
Medical Device Regulatory Submissions
She has extensive experience writing and compiling 510(k)s and PMAs for product clearance or approval with a well-established track record of success. Some of the device types she has experience include Surgical Instrumentation, Cardiac Ablation Systems and Catheters; Surgical, Ophthalmic…
Biostatistics, Epidemiology, Methodology, Mental Health, Police Procedures, Drug Safety, Malpractice
As a Professor of Statistics, Epidemiology, Public Health and Psychiatry for the last 30 years he has taught, applied and consulted on all of these methods. First trained as public health physician, he did his graduate work (MS and PhD)…
Litigation Support, Sentencing Mitigationt, Expert Testimony, Due Diligence.
Law enforcement officials in this country are, by statute, vested with more authority than the President of the United States. Simply, they are the only individuals who can initially deprive a person of their personal freedom without due process and…
Cleanrooms, Contamination Control, Ultrapure Media, Qualification and Validation, GMP, AMC
Expert has been active in aersol physics for more than 25 years. His PhD covers also the areas of environmental, indoor and cleanroom aerosols. He worked in a variety of scientific and technical projects covering the health effects of particles…
Medical Device Regulatory Support, Medical Device Registration, etc.
Expert is a Regulatory and Quality Consultant with strong team building skills for high technology corporations. A hands-on career of increasing leadership positions with a broad range of responsibilities in manufacturing, regulatory affairs and new product introductions. A committed professional…