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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…
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…
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…
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…
Equipment Validation
Experienced pharmaceutical process engineer with demonstrated ability in managing, supporting, and formulating in a dynamic environment. EQUIPMENT EXPERIENCE Ackley Imprinter Glatt - GPCG-1, GPCG Pro-5, VG Pro 65, Midi Glatt, VG-25, Glatt SKS-100 valves. Korsch - XL400WIP,…
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…
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…
Coatings; Powder, liquid, Electrocoating and metal finishing process
As a Continue Improvement Manager (holding a Managerial position company deems fit), Expert is offering his engineering education, managerial experience, training in Lean manufacturing principles and Kaizen facilitation expertise to Operations, Business Unit or Production Area at a Manufacturing, Pharmaceutical,…