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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…
Medical Device Engineering
He worked on hazard analysis of medical devices such as biochemical sensors. He worked on packaging processes of medical devices such as implantable catheters. He worked on packaging materials of medical devices such as plastic packaging. He worked on manufacturing…
Quantum Dots, Nanocrystals, Nanomaterials, and Surface Chemistry
Expert holds a Ph.D. in chemistry and has worked in the area of nanomaterials and surface chemistry. In particular, he has worked with quantum dots (semiconducting nanocrystals) for over 10 years and now has multiple publications in this field. Expert…
Medical Device Regulatory Affairs: CE (Canada) and FDA
Expert has 25 years' experience in FDA, TGA, CE, and Health Canada product approvals for medical devices and combination devices. He has experience writing CER, CE applications, FDA applications, TGA and Health Canada applications. He has performed PMS, PMCF, recall,…
Business Process Outsourcing, Technology and Sales, and Business Development
Expert is an experienced, consultative, and creative leader. He specializes in maximizing satisfaction for clients and owners alike, consistently doing so with a high level of personal integrity. He earned his MBA in Management Consulting in London, which has contributed…
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…
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…
Air Medical, Critical Care, Trauma, Emergency Medicine, RN
Expert has worked as a nurse in critical care, emergency and trauma for the past 20 years. For 17 of the 20 years, she has been in transport nursing. She has been a flight nurse for 15 years. A definitive…
Medical and Semi-Conductor Machinery Design and Manufacturing – Solidworks Modeling
Expert has designed precision machinery for 25 years. Much of this was for semi-conductor companies at which time he gained extensive experience is high speed applications requiring the use of piezo-electrics, air bearings, FEA modal analysis. He received a patent…
Parenteral/Sterile Product Formulation Development; Protein Peptide Formulation; Drug Delivery
Former Director, Formulation Research, Hoffmann-La Roche Inc.- primarily parenteral formulation and drug delivery systems – Extensive experience in the areas of formulation, drug delivery and clinical manufacturing - Member of Global Formulation Research Leadership Team – Four successfully launched peptide/protein…