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Medical Device Regulatory Affairs, Quality Assurance, FDA 820 EU ISO 13485 510(k) & Medical Software
Lead and developed regulatory plan and strategy for Molecular Diagnostic System. Blood Analyzer, Gene Profiling Reagents, Blood Analyzer etc. Assembled with team regulatory submission and obtained 510(k) clearance, EU CE Mark, Health Canada, China SFDA, Mexico, Australia, South Korea, and…
Pharmaceutical Formulation, Drug Delivery, CMC, NDA, and Formulation Patents
Expert has developed multiple immediate release and modified release oral formulations at ALZA Corporation and at Transcept Pharmaceuticals. Many of these formulations have been commercialized including Invega (OROS paliperidone) and Exalgo (OROS hydromorphone). Recently, Expert was instrumental in developing a…
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…
Pharmaceutical Development; X-ray Computed Tomography; Tabletting; Particle Technology
Expert. Expert has extensive experience in numerical modelling particulate material manufacturing and characerisation, modelling and characeristion of the behaviour of particulate materials during the manufacturing processes for pharmaceutical and other particulate products at microscopic and macroscopic levels. In particular, he…
Analysis, FEA, CFD, Medical Devices, Heat Transfer, Elastomers, Diffusion, Solar, Coupled Systems
Real invention and innovation most often springs from cross-fertilization and analogies from broad experience, quite apart from an entire career in a narrow field. See, for instance, Holyak and Thagard, "Mental Leaps: Analogy in Creative Thought". Expert is a broad…
Rheology, Nanotechnology, Particulate/Multiphase Processes, Chemical Engineering.
Expert operates his contract research & development small business incorporated in 1990 in Saint Paul, Minnesota, USA. Expert's professional experience spanning over four decades in chemical engineering has focused around the broad areas of particulate/multiphase processes and rheology. Chemical engineering…
Chemical and Pharmaceutical Development – Comprehensive CMC
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…
Medical Device Software, Safety Critical Systems, Embedded Systems Design
Expert managed the Electrical Engineering department of a consulting company specializing in medical device design. He has designed software, firmware and hardware for medical devices including a Proton Beam Radiotherapy system, blood infusion pumps, blood analyzers, hysterscopic pump, drug scanning…
Chemometrics, Data Interpretation, Statistics and Mining in Analytical Chemistry
He has 25 years experience in data analysis primarily involving analytical chemical data analysis, often called chemometrics. Application areas include biology (e.g. metabolomics of humans and mice, microbiology), medical applications (e.g. TB analysis in breath, salival analysis in dentistry), pharmaceuticals…
Pharmaceutical Development, strategy planning and execution
Expert graduated in Biology at the University of Utrecht, The Netherlands, in 1984. From 1985-89 he was a PhD student at the University of Basel. The research in the field of gene regulation was carried out at the Friedrich Miescher…