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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…
Medical Devices, Pharmaceuticals, CMC, Regulatory Affairs, R&D, Design Controls, Autoinjectors, Syringes, and Manufacturing
Expert has extensive experience in Pharmaceutical and Medical Device industry. He managed multiple departments and spearheaded combination product activities to launch products. This included FDA/EMA meetings, Human Factor activities, Device Design and Development, Regulatory submissions, and Manufacturing responsibilities. He has…
Medical Devices, Combination Products, Biotech, Pharma, R&D, Operations, Manufacturing, and Supply Chain
Experienced global leader of R&D, Technical Operations, and Manufacturing organizations. Industrial focus in Medical Devices, Small Molecule Pharmaceuticals, Biotech, Packaging/Labeling, and Combination Products. Broad functional experience in the fields of Project and Personnel Management, Logistics, Supply Chain, and Finance. Successful…
Medical Devices
Expert has about 10 publications on ablation. He published papers on this area and had grants to develop radio-frequency cardiac and liver ablation systems. He founded and directed a laboratory for medical device testing under IEC standards. Overview of Skills:…
Dental Medical Device Industry
Expert is a marketing and advertising professional with a decade of experience in the cosmetics and dental industries. She is currently a marketing consultant at Bio-Concept Dental Implants (as of 1/2016). Prior, Ms. Expert was a Product Manager for the…
Intellectual Property, Patents, and Medical Devices
Expert is an award-winning, Oxford-educated scientist with expertise in electronics, medical imaging, medical devices, sensors, semiconductors, MEMS, image processing, and signal processing. He has been deposed in a patent case. His experience spans a variety of industries and applications, including…
Fluoropolymers and Surface Modification of Materials
He is an expert in fluoropolymers plant design, start-up, upgrade and quality improvement. He developed this specialty particularly at DuPont (U.S.). This expertise has been augmented throughout his career in USA, China and India start-up, plant upgrade and quality improvement,…
3D Printing / Additive Manufacturing, New Product Development, Innovation Management, Growth Strategy
Expert is a managing director at company where he works with companies on business development, innovation management, technology commercialization, and product strategy. Expert is also the co-founder of a consultancy focused on design strategy and additive manufacturing for accelerated product…
Medical Device Pathology
His areas of expertise include the following: • Inflammation and vascular cell biology/pathology • Medical device, drug delivery, and biomaterials histopathology • All phases of preclinical research • Regulatory, R&D, sales and marketing, and clinical issues He was a founding…
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…