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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…
Psychology, Internal Medicine, Rheumatology, Clinical Medicine, Chronic Pain Management
Expert is a Board-Certified Rheumatologist (additionally with Boards in Internal Medicine). He possesses extensive experience and expertise in Immunology as well. Expert's official title is Associate Clinical Professor of Medicine and Cedars Sinai Medical Center. He is also self-employed. Appropriately,…
Pharmacokinetics/Pharmacodynamics
Expert has over 37 years of experience in the pharmaceutical industry, including work as an independent consultant. As a consultant he offered preclinical and clinical pharmacokinetic, pharmacodynamic, and pharmacometric support services, with emphasis on providing strategic planning services throughout a…
Pharmaceuticals
During Expert’s 30 years in Pharmaceutical Research and Development, he developed extensive expertise in novel drug delivery systems and assessing external drug delivery companies while at Parke-Davis/Warner-Lambert, Pfizer and SCD Pharma Consulting. He also managed a team of scientist developing…
Formulation
Pharmaceutical product development, scale-up, commercial manufacturing. Process design, improvements, economic changes. Complex product development, bioavailability, absorption enhancement. Intellectual property analysis and guidelines for alternative strategies. Sourcing, quality, regulatory CMC guidance. Proven track record of 30 years in effective product development…
Sourcing / Procurement / SCM Functions
Expert is a seasoned Procurement / SCM professional with over 30 years of industry experience with a reputed diversified group of companies. He has been heading Procurement / Sourcing / SCM functions in a complex business environment for 23 years…
Oncology, Hematology
ACADEMIC BIO SKETCH: Expert holds the rank of Professor of Hematology/Oncology, is a 33 year veteran of academic medicine, a key opinion leader and skilled principal investigator of over 200 clinical trials and has published over 100 peer-reviewed articles in…
Pharmaceutics
Excipients are broadly defined as any pharmacologically inert components other than the active pharmaceutical ingredient (API) that are added intentionally to the pharmaceutical formulations. Unintentional variability in the properties of the excipients may have a range of influences on their…
Pharma/Biotech Market Access, Pricing & Reimbursement, Business Development Europe and Latin America
Pharmaceutical executive with 17+ yrs. experience in international, corporate and local/regional roles at leading pharmaceutical companies in Europe and Latin America. Strong experience in general management, business development and licensing, alliance management, project and transition leadership, marketing and sales, strategic…
RFID (Radio Frequency Identification)
Expert is a leading technology consultant with over 20 years of experience in the international arena. His expertise spans a variety of industries: Healthcare, Logistics, Transportation, Manufacturing, TMT and others. He assists organizations in helping manage change through process improvement…