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Medical or Pharmaceutical R&D and Manufacturing – New Product Approval and Launch Including FDA, EMA, and Asia
40 years in design, manufacturing, R&D, and compliance. For the last twenty years have directed and led projects leading to over thirty 510(k), PMA, and NDA approvals in drug delivery, ophthomalogy, dental, cosmetics, emergency medicine, obstetrics, oncology, and diabetes. Clients…
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…
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…
Regulatory Sub. NDS, ANDS, SANDS, NC, Cross References, Natural Health Products, Medical Devices
Expert's firm has extensive expertise in regulatory submission. They provide different regulatory strategies to their customer’s and prepare all types of submissions on their behalf. Expert also has extensive expertise in Narcotic’s regulations. Moreover, her firm has extensive experience in…
Aquatic Safety: Swimming, Drowning, Cervical Spine/Diving, Boating, Hypothermia, Alcohol, and PFD\’s
Expert retired as a U.S. Coast Guard Commander. His last tour of duty was as Chief of the Boating Safety Division, Second Coast Guard District. As such, he was responsible for overseeing federal boating safety efforts in education, engineering and…
Polymer Chemistry, Optical Polymers, Organic Chemistry
Acrylic resins or "acrylics" as they are more commonly known in the trade, are dominated by a relatively few number of molecules such as butyl acrylate and methyl methacrylate. However by esterifying acrylic or methacrylic acid it is possible to…
Industrial Hygiene, Non-Friable Asbestos-Containing Materials, Formaldehyde, Silica, Indoor Air Quality, Mold, Accident Investigation, Auditing and Hazard Assessment
He has conducted numerous indoor air quality and environmental mold assessments for commercial and residential environments. Assessment includes monitoring for applicable indoor air consituents, developing corrective action plans, and verification of correction/efficacy. He also lead the indoor air quality committee…
Biotechnology, Enzymes, Environmental Bioremediation, Regulatory Compliance
Expert has over 40 years of experience in both basic and applied Biochemistry (biochemical research and enzymology) and Biotechnology. He is very successful in finding flaws in published and spoken materials. His strengths are in the fields of physical biochemistry,…
Nanotechnology, Biomaterials, Sol-gel Sciences, Optics, Biotechnology, Glass, Ceramics, Spectroscopy
Expert is a specialist of sol-gel chemistry. He developed a new non-aqueous method for sol-gel glass coating to obtain transparent films for integrated optics and photonics using polysiloxane materials. The aim was to obtain low-softening temperature glasses to permit facile…
Transportation, Safety, Railroad, Bus, Highway, Pedestrian, Passenger, Bicyclist, Workplace, Parking
Expert is a transportation and traffic engineering expert and has served as a litigation consultant since 1997. Because of expert’s 50 years of expertise, he is frequently consulted at the initial stages of a potential litigation for impartial input that…