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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: 735397 Connecticut, USA

Expert in Pharmaceutical Development

He brings 38 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: 732491 Washington, USA

Expert in Pharmaceutical Manufacturing, Combination Products, Medical Devices, and Good Clinical Practices

Expert is a retired Public Health Service (PHS) Officer with 16 years of FDA experience in Pharmaceuticals, Medical Devices, Biologics, and Bioresearch Monitoring. She has held the positions of Investigator, Pre-Approval Manager, Supervisory Investigator, and Foreign Inspection Cadre Member. She…

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: 730909 Texas, USA

Expert in Commissioning, Start-up and Validation of Biotechnology and Pharmaceutical Processes

Expert has over 30 years' experience in research, development, QA/QC, technical service, validation, manufacturing and engineering management. All of the above have taken place in the food, pharmaceutical and biotechnology industries. Expert has formal training in microbial physiology, biochemistry and…

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…

Expert ID: 729549 California, USA

Expert in Pharmaceutical Quality Assurance, Quality Control, Supplier Selection and Supplier Quality

Expert has extensive expertise in GMP matters in the pharmaceutical and medical device industries. During his 20 years in industry, he devised, managed and led programs to assure compliance to drug GMPs, GLPs and GCPs. Key areas of expertise included…

Expert ID: 728603 Massachusetts, USA

Expert in Chemistry R&D and cGMP Manufacturing, Pharmaceutical Development

Expert has worked on research, development and manufacturing problems involving stereochemistry throughout his academic training and industrial career. Relevant examples include: development of scalable chiral and asymmetric syntheses; improvement of reaction stereoselectivity; tracking of chiral integrity in chemical processes; chiral…

Expert ID: 726302 Australia

Expert in Formulation, Development and Manufacturing of Pharmaceutical Dosage Forms

Expert has extensive product development experience in solid dosage forms (TABLETS {IR & ER} HARD & SOFT GELATIN CAPSULES AND POWDERS); Liquid dosage forms ( SOLUTIONS, SUSPENSIONS & EMULSIONS) from conception through to stability trail, clinical studies, validation; final manufacture,…

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