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Expert ID: 723693 Florida, USA

Expert in Pharmaceutical Science; Preformulation, 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…

Expert ID: 735397 Connecticut, USA

Expert in Pharmaceutical Development

He brings 39 career-years’ experience, including service at FDA as a Review Chemist. He began his career in pharmaceutical research and development with Purdue Pharma (Stamford, CT – MS-Contin®, Uniphyl®, Oxycontin®)(3 years), and continued on to Bayer (West Haven, CT…

Expert ID: 735196 Massachusetts, USA

Expert 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…

Expert ID: 734127 New York, USA

Expert in 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…

Expert ID: 733446 North Carolina, USA

Expert in 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…

Expert ID: 732555 United Kingdom

Expert in Pharmaceutical formulation, process development and manufacturing of products

Extensive experience in formulation design and manufacturing process development and optimization gained working for large, medium and smaller companies.Having worked on the development of a relatively large number of small molecules at all stages of development, Expert has gained specialist…

Expert ID: 731747 California, USA

Expert in Product Development and Regulatory Approval of In-Vitro Diagnostics and Companion Diagnostics

PhD in Biochemistry, MBA in Business and RAC (US) Certification with 15 years of experience in diagnostic assay and system development at top global in-vitro diagnostic (IVD) companies including Roche, Bio-Rad Labs, Siemens Healthcare Diagnostics and Thermo Fisher Scientific. A…

Expert ID: 731583 Florida, USA

Expert in Pharmaceutical Development

Expert has over 28 years experience as a pharmaceutical executive managing various aspects of drug product development, including outsourced pharmaceutical manufacturing and broad aspects of the CDMO industry. Previously, Expert was the President of Pharmaceutical Development Services and the Chief…

Expert ID: 729777 Oklahoma, USA

Expert in Pharmaceutical Product Development, Dosage Forms, Controlled Release, QC/QA, GMP, China

Expert has worked in the pharmaceutical industry as a research scientist, QC/QA director, vice president of product development, and has been involved in product development from pre-clinical through Phase 1 production. Expert has experience in setting up a cGMP manufacturing…

Expert ID: 729706 Connecticut, USA

Expert in Pharmaceutical Manufacture and Supply in Startup New Product Companies & Acquisition Integration

Expert has successfully developed and led a diversity of complex operations and projects in a variety of cultures and environments. These range from turnarounds and startups of flagship greenfield operations to cross functional teams in world-wide new product launches, and…

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