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Pharmaceutical & Life Science Research and Manufacturing, New Drug Discovery, Therapeutic Strategy
By using standard analytical tools of cellular and molecular biology he has elucidated the molecular mode of action of an anti-diabetic candidate BMOV on the key components of insulin signaling cascades like IR Kinase (IRK) and IRS complexes including gross…
Pharmaceutical Development, CMC, Project Management, Intellectual Property
Expert has developed modified release products throughout his career. Most recently he led the development of proprietary oral modified release systems at Phoqus Pharmaceuticals. These included zero-order, increasing-rate, pulsatile, delayed-release, chronotherapeutic and fast-release formulations. Prior to that he was responsible…
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,…
Operational Streamlining, Organizational Transformation, Program Management, and Technology Integration
Expert has extensive experience in Software Project Management of over 20 years in federal and commercial sectors. He has managed projects involving application development, system integration that required integration of commercial software products (COTS) with application code, software conversion, and…
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…
Analytical Chemistry, Analytical Technology Development and Application
Expert is a Ph.D. Pharmaceutical Analytical Chemist with extensive experience in separations (LC, GC, Prep GC), dissolution, automation (robotics, computers) and general analytical technologies. He has familiarity with NDA programs and marketed product support, including analytical method development, process support,…
Medicine, Pharmacy, Pharmacology/Toxicology with Emphasis on Cannabanoids and Opioids
Expert is a practicing physician and pharmacist, who also holds a Master's of Science degree in Pharmacology and Toxicology. He has performed research in the field of Pharmacology with particular focus on drugs of abuse, cannabinoids and opioids. He has…
Pharmaceutical Analytical Chemistry, Cosmetic Analytical Chemistry, Mathematics, General Science
Expert is a retired chemist with over 35 years of experience in the cosmetic and pharmaceutical industries. He evaluated and dispositioned all raw ingredients used in manufacturing cosmetics and OTC cosmetics. He developed a reduced testing program to improve efficiency…
Medical Pharmacology and Toxicology
Expert is a medical-legal consultant who specializes in cases that relate to drugs and drug pharmacology/toxicology. He has over 20 years of experience. Expert has experience in civil, criminal & administrative cases--both plaintiff and defense. Expert has been certified as…