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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,…
Large Animal pharmacology/pharmacokinetics, Sterile products,GMP,Product Development, Safety and ID
Expert has training is antimicrobial monitoring and reporting to Blue Cross/Blue Shield of hospital infectious diseases. She is an occupational safety officer for laboratory animal programs and a pharmacy safety instructor. She has completed GMP training to include auditing in…
Medical Devices, Biomaterials, Due Diligence, Business Development
Expert has extensive research and development expertise having spent over 20 years in the development of orthopaedic implants. This lead to over $1billion in sales. The technologies developed included calcium phosphate cement, 2 different calcium phosphate coatings, biodegradable implants and…
Cardiac Electrophysiology, Cardiology Drugs, Pacemakers, Defibrillators, Cardiac Medical Devices
Expert. Expert is a board certified cardiac electrophysiologist (cardiologist with expertise in the diagnosis and treatment of all cardiac rhythm disorders) with over 20 years experience as a clinical investigator, IRB Chair, and high volume implanter of cardiac rhythm devices.…
Infectious Diseases, Infection Control, Healthcare-Associated Infections, HIV/AIDS, Med-Peds
Expert S. Expert, FACP, FAAP, FIDSA, AAHIVS is Clinical Professor of Medicine and Pediatrics at the Employer and Hofstra North Shore-LIJ School of Medicine in New York and former Global Medical Director and Senior Vice President for Pall Corporation. After…
wound healing, burns, clinical research, FDA regulations, drugs, devices, medical writing
Expert provides scientific knowledge and regulatory background to assist companies in the research and development of clinical, animal and laboratory studies designed to promote pharmaceutical drugs and medical device products specializing in wound healing and burn care. Additional Services: •Development…
Clinical Practice of Infectious Diseases, including HIV
Expert has decades of experience in managing all aspects of myriad infectious diseases.
Hydrogel Science and Technology for Drug Delivery, Medical Devices and Consumer Products
Expert’s major contributions are in microbial control of wide range of medical devices and pharmaceuticals. He has a background in chemical engineering and polymer science. He has decades of experience from numerous companies- large device and pharmaceutical companies to startups…
Surface Engineering, Diamond like hard coating, material science, Medical device, hard disk
Most of Expert's scientific career has been devoted to the development of surface modification and thin film deposition technologies, including plasma nitriding, plasma carbonization, boriding, chromizing, cathodic arc, filtered cathodic arc, pulsed laser ablation, magnetron sputtering, pulsed mid-frequency dc magnetron…
Nanobiotechnology, Drug Delivery Platforms, Medical Devices, Targeted Therapeutics, Diagnostics
Expert has extensive experience establishing R&D operations in early stage biotechnology companies. He applied his knowledge in nano(bio)technology to develop innovative solutions to drug delivery and drug targeting challenges. His efforts to enhance the use of biomaterials in a variety…