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Practical Application of GLP, GCP, and cGMP to Pharmaceutical, Device, and Biotechnology Firms
As Vice President at a pharmaceutical company, Expert formulated eight pharmaceuticals for use in their patented buccal delivery platform technology. Five formulations were acceptable to FDA and were allowed to proceed into human clinical trials under IND controls. Four of…
Microbiology, Biotechnology, Cleanroom Microbiology, Sterilization, etc.
As a consultant, Expert has used his broad-based scientific background to work with a variety of clients. These clients have required expertise in such widely divergent subjects as the production of cellulosic ethanol (requiring a knowledge of basic thermodynamics, enzyme…
Clinical Applications, Microbiology, Biotechnology, Diagnostics, Immunology, and Custom Speaking
Expert has been involved in the identification of biological molecules associated with disease and infection with bacterial and viral agents. By applying molecular techniques to vaccine and infection models, he has identified immunological (antigenic) markers of bacterial infections of human…
Facilitating Business Growth Through Commercialization of New Medical and Biotechnology Products
Expert has extensive experience supporting clients in pharmaceutical, medical and industrial markets. An electrical engineer by training, and the principal of his own consultancy for more than 12 years, he brings strong market, business development and technical skills to his…
Oxygen Therapy & Conservation, Biofeedback, Clinical Management Design, Electronics, & Prototyping
Expert L. Expert has extensive clinical experience in asthma management and served on the ATS Standards Committee for COPD (Chronic Obstructive Pulmonary Disease). He developed an asthma clinical guidance system, developed three biofeedback systems particularly for asthma. He also developed…
Biomaterials and Product Development R&D for Orthopedic, Cardiovascular, and Other Implants
Expert has helped assemble, and been lead author on 510(k) and IDE applications to the FDA. This has often included telephone conversations, and occasionally personal visits, with the FDA to discuss unique aspects of the devices and/or materials in the…
Anesthesiology, Physiology
ExpertPaul Expert is an Associate Professor and Director of Research in the Department of Anesthesiology at the Employer. He has a joint appointment in physiology and is a core facultly member in the biomedical engineering institute. Prior to this, Expert…
Automated Chemical Sensors
LABORATORY COMPUTERIZED ANALYTICAL INSTRUMENTATION DESIGN; CHEMICAL AUTOANALYSIS. Expert has spent much of his career developing systems or subsystems for devices accomplishing automated chemical analysis. He has experience in all phases of this process, from basic research into sensors to the…
Animal Models, Preclinical Testing, GLPs, Protocols, Data Capture Forms, Veterinary Medicine
Expert has a significant amount of experience with developing animal models through discussions with cross-functional groups and considerable expertise in veterinary surgery and biomechanics. He has experience with animal models for the cardiovascular, peritoneal, gastrointestinal, cutaneous, reproductive, urinary, and skeletal…