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Clinical Research, Clinical Trials, Drug Development, Drug Safety, Patient Consenting Process
Experienced clinical research professional with a demonstrated global leadership in the pharmaceutical and medical device industry. Global organization and oversight of clinical research, QA and regulatory strategies. Leadership in new business development (medical device and medical software development quality management,…
Eye Disease, Eye Surgery, Ophthalmic Drugs and Drug Development, Ocular Trauma, Oculr Med-Legal
Expert is a Johns Hopkins trained ophthalmologist who combines a full-time clinical practice with ophthalmic med-legal and ophthalmic pharmaceutical industry work. His other interests include innovations in cataract and other types of ophthalmic surgery, operating room efficiencies and infection control,…
Pharmaceutical, Drug, Medical Device, and Management
Expert is a Pharmacist and an Attorney with a MBA and has worked in the pharmaceutical/biotech/medical device industry for 25 years.
Pharmaceutical Sciences (Small Molecules and Peptide Delivery), Novel Drug Delivery (Micelles, Liposomes, and Insitu Forming Gel), and Conventional Dosage Forms (Solid, Semisolid, and Liquid)
Expert is an experienced pharmacist with a demonstrated history of working in the pharmaceuticals industry. A skilled researcher, she is knowledgeable of R&D development in Pharmaceutics (small molecules), cosmetics and OTC (herbal products). Expert is experienced in industry and academic…
Methodology, Latin American Politics, Drug Policy Making, Politics and Policy Making
HIGHLIGHTS OF QUALIFICATIONS - 25+ years of successful experience as a Public-Sector Consultant and Policy Analyst, working with a variety of organizations including research centers, universities, Latin American Government agencies, consulting firms & international agencies. - Solid conceptual skills demonstrated…
Pharmaceuticals, Drug Delivery, OTC, and Rx products
Expert actively consults in nearly all routes of drug delivery, including oral, transdermal, topical, inhalation, injection/infusion, nasal, buccal and others. He holds a Ph.D in Polymer Science and Engineering, as well as an MS on the same topic. He holds…
Police Dogs, Drug Dogs, and Police Canine Training
Expert has trained over 300 Police Service Dogs and Handlers in Tracking, Patrol, Narcotics & Explosive Detection. He has been certified as a Canine Trainer by the New York State Bureau for Municipal Police as well as the Ohio Peace…
Pharmaceutical Formulation, Process Development and Manufacturing of Products Focusing on Poorly Water Soluble Drugs
Extensive experience in formulation design and manufacturing process development and optimization gained working for large, medium and smaller companies.Having worked on the development of a relatively large number of small molecules at all stages of development, Expert has gained specialist…
FDA Regulatory Expert Witness Regarding Medical Devices, Drugs, Software and Data Integrity
Skilled at writing expert reports that describe and explain regulatory and compliance-related issues involving FDA-regulated companies. Talented in depositions and testimony. Specialist in analyzing drug/medical device-related safety data and FDA compliance information to answer three questions: 1) What did the…
Food Labeling; Food, Spring/Bottled Water, Drug and Medical Device Good Manufacturing Practices
Expert was a California Food & Drug Investigator for 26 years enforcing federal GMPs and California health & safety codes. She has traveled throughout California inspecting a wide range of wholesale food, drug, and medical device manufacturers. She was responsible…