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Pharmaceutical Science; Preformulating, Development, Chemistry, Manufacturing & Control (CMC) Issues; Paragraph IV Hatch-Waxman & Canadian Notice of Allegation
As the development of a pharmaceutical reaches Phase 3, prior to submission of an NDA, method validation is required. Validation is a demonstration of optimization. By demonstrating the capacity of a method within the bounds of validation, optimal conditions for…
Psychiatry and Mental Health
Expert graduated medical school from Ross University, completed her internship in Internal Medicine at Beth Israel Medical Center in New York City, then completed a three-year Postdoctoral Fellowship in Brain Stimulation and Neuroimaging in Mental Illness at the University of…
Biocompatibility Testing and Biomaterials for Medical Devices
Consulting experience in the set up and protocols for biological tests, pre-clinical evaluation submission summaries (regulatory), product (medical device) cleaning validation, GLP laboratory set up and management, biocompatibility/ toxicilty testing Strategy for the pre-clinical evaluation / toxicity testing of an…
Physical Therapy
1969 B.S. SUNY Downstate College of Health Related Professions, 1971 M.S. Exercise Physiology Long Island University, Masters Degree Thesis: A Comparison of the Effectiveness of Eccentric Vs. Concentric Strength Training Programs on the Contractile Strength of the Elbow Flexors. 1995…
Neurosurgery/ Complex Spine Surgery
Expert is an academic neurosurgeon specialized in complex spine/deformity surgery, currently practicing as Assistant Professor at the Division of Neurosurgery at very prestigious university. During the past years, he has had the privilege of teaching and mentoring several residents in…
Medical Device Quality Assurance and Regulatory Compliance
Expert is a 34-year food, cosmetic, drug, biologic, clinical, medical device, and combination product non-technical quality assurance and regulatory compliance veteran with over 21 years of FDA/ governmental experience as an analyst and level II certified international medical device investigator…
Medical Devices, Diagnostics, Digital Health
Expert has 20 years of leadership experience in medical device/life sciences marketing in small start-ups and Fortune 100 companies. Following an industry career Vice President of Marketing for Oridion (acquired by Covidien) Medical, Director of Marketing for Philips Medical, and…
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,…
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.
Healthcare Strategy, Technology & Innovation
Expert has 20+ years of experience in the healthcare industry. He is currently a Principal at a healthcare consultancy focused on health care strategy, technology, and innovation. He offers advising services like topic-specific research, environmental/market assessments, strategic planning, operations/workflows design…