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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…
pharma, regulatory, cosmetics, biosimilars
The expert is having a post-graduate degree in pharmacy which is duly recognized by the University of Toronto and is currently working as Senior Regulatory Associate at the apex drug regulatory body in India i.e CDSCO. He is responsible for…
soy products utilization, nutritional product formulation, probiotics and prebiotics, nutritional clinical study designs
An accomplished and global clinical and nutritional leader with over 25 years of progressive experience in the botanicals, nutritional vitamins, prebiotics/probiotics, multinational healthcare, and consumer products industry sectors. Demonstrated leadership in partnering with internal technical and cross-functional operating teams in…
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…
Biopharmaceutical Process and Product Development; Patents and Trade Secrets in the Biotechnology Industry; and Biosimilar Patent Infringement
Expert is a classically trained biochemist with 30 years of experience in the biopharmaceutical industry as both a hands-on scientist and scientific leader in process, analytical, and formulation development, product commercialization, and product quality assessment. During his long tenures at…
Medicated Aerosol and Inhalers
Expert has been in the field of Medicated aerosol (MDI, DPI and nebulizers) since 2004. His PhD was in this field and most of his 77 published paper and 48 conferences presentations are in this field. Expert has a respiratory…
Pharmaceutical Formulation
Expert received his M.S. and doctorate in Pharmaceutical science from Long Island University, Brooklyn campus in 2017. During his doctoral dissertation, he worked on the rheological characterization of transdermal formulation and application of rheological models in product development and scale-up…
Formulation Liquids, Soft Gelatin, Two-piece Hard Capsules, and Process Development in Pharma
Expert has developed Soft Gelatin Capsules containing non-aqueous solution, suspension and self-emulsifying formulations for a variety of new chemical entities (NCE), prescription, highly insoluble compounds and OTC drugs. This experience included conducting solubility studies with hydrophilic/lipophilic excipients, as well as…
Pharmaceutical Formulation (Tablets, Capsules, Semi-solids, Liquids), QbD, and CMC Regulatory/Risk Assessment Issues
Expert is a Pharmaceutical Formulation Scientist with 25+ years' industry/FDA experience developing and commercializing tablets (fast dissolving, effervescent, chewable, coated), capsules, ODT's, coated beads (i.e., controlled release and taste-masked), topicals (liquids and semi-solids), & CBD/hemp products. He also has experience…