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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…
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…
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…
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…
Food Science & Technology, Project Portfolio Management, and RD&I
As a food scientist with 25 years of experience in product development and a passion for sharing knowledge, Expert's mission is to help entrepreneurs and businesses overcome those challenges, providing immediate access to food innovation expertise. Experienced in the commercialization…
Toxicologist, Dietary Supplement and Functional Food compliance
Experienced toxicologist with knowledge of product formulations, regulatory requirements, and analytical evaluation of test results. Worked as a toxicologist for NSF International for 15 years in dietary supplements and functional foods. Have been self-driven and working from home for the…
Medicinal Chemistry and Pharmaceuticals
Expert's services have been retained in a high-profile ANDA case against Pfizer. Expert was deposed and participated in pretrial preparation. He has recently provided expert witness consulting services in a case for a nutraceutical company, where he was deposed and…
Computed Tomography Expert
I have worked in Radiology for 25 years. I started as an X-ray tech and have specialized in Computed Tomography (CT) since 1996. I am also a clinical Radiation Safety educator for CT. I well skilled and knowledgeable in best…
Pharmaceuticals: Formulations, Injectables, Topicals, Analgesics, Pharmaceutical Analysis
CORE SKILLS Instrumentation skills. APIs/preformulation: X-ray diffraction; Raman spectroscopy; HPLC (potency, degradants, purity, linearity, accuracy, precision, LOQ, LOD) with detection via UV-Vis, fluorescence, and conductivity; content uniformity, dissolution/elution incl. sustained- and immediate release formulations, paddle wheel apparatus; forced degradation incl.…
Pharmaceutical Development
Expert is a former FDA Review Chemist, with > 39 years of career experience in pharmaceutical R&D, Quality Operations and Regulatory Affairs. For 25+ years as a consultant in his own pharmaceutical development advisory firm, Expert has furnished clients with…