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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, 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…
Clinical Trial, Biomarker, Clinical Development, Drug Safety, Medical Affairs, Commercialization
As a prescribing physician and a physician in drug development for many years, Expert has expertise in drug mechanism of action and clinical data, and clinical use. Expert is an expert in drug clinical development from planning to protocol design,…
Optical Instrumentation Design, 3D Imaging, Confocal Microscopy, OCT, FTIR, Laser Scanning
Expert in the design and function of confocal microscope systems. Holder several patents for original confocal systems designed the semiconductor, glass, and other industries. Expert in 3D imaging technologies including laser triangulation, moiré', confocal imaging, and interferometry. Expert has designed…
Japanese Technology, Patents, Risk Management, Due Diligence, Fraud, Investigations
It can be as simple as applying the wrong concentration of herbicide, pesticide or fertilizer to agricultural machinery related accidents. Drift of chemicals from treated areas to neighbouring areas which damage people or crops is another example. Although some define…
Drug Delivery, Drug Development, Business Development, IP Strategy, Medical Nanotechnology,
As a business development exectuive and as CEO of several life sciences companies, he has had the opportunity to be closely involved and lead the identification, negotiation and closing of a number of licensing and R&D agreements with pharmaceutical, biotechnology,…
Medical Consulting, Medical Writing, Effective Ad Strategies Targeting Physicians
Expert is a physician and medical writer with 16 years of experience. He has written research protocols and completed the studies while at NYU Medical Center. While in clinical practice, he published 8 articles in medical journals and published 5…
Stroke, Preclinical Drug Development, Translational Research
Expert A. Expert, PhD. FAHA is the Director of Translational Research at Employer in Los Angeles, California. He is directing the preclinical development of new methods to treat acute ischemic stroke. Expert has expertise in developing small molecules, proteins and…
Developmental and Reproductive Toxicology Study Design, Data Evaluation, and Report Review
Expert (prefers “Expert”) has acquired knowledge and expertise on birth defects in three ways: 1) teaching university courses on human embryology and on causes and manifestations of birth defects; 2) conducting lab animal research; and 3) extensive technical consulting and…
PK/PD Modeling and Simulation; Nonclinical and Preclinical Statistics; Experimental Design
He managed group of 5 biostatisticians working on Phase I and PK/PD trials. His responsibilities included protocol design, statistical analysis plan writing, specification writing, and delivery of product to customers. He was responsible for meeting all timelines and budgets, assuring…