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CLIA/CAP/NYS Laboratory Testing; Tissue/Cornea/Live Cell Donor Suitability
Expert is one of the world's leading experts on eye and tissue banking, as well as being a pioneer in the field of personalized medicine. His company provides CLIA-qualified laboratory directors to labs throughout the United States, as well as…
Commissioning, Start-up and Validation of Biotechnology and Pharmaceutical Processes
Expert has over 30 years' experience in research, development, QA/QC, technical service, validation, manufacturing and engineering management. All of the above have taken place in the food, pharmaceutical and biotechnology industries. Expert has formal training in microbial physiology, biochemistry and…
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…
Pathogen Detection, Rapid Methods, Food Preservation, Antimicrobial Effectiveness Testing, Herbs
Expert has extensive experience (20+years) in food microbiology research including molecular pathogen detection methods and antimicrobial effectiveness testing. She has provided technical leadership and contributed expertise to develop and evaluate DNA-based methods and immunoassays for detection of pathogens including E.…
Food & Drug Administration Rules, Policies, Procedures for Medical Devices and Pharmaceuticals
Expert is an FDA compliance expert with 28 years experience in the field. He served the U.S. Food and Drug Administration as an Investigator concentrating in compliance for pharmaceuticals and medical devices as well as pre-market development of drugs and…
Immunology, Biotechnology
Expert Gutierrez has worked on research projects concerning the mechanisms of regulation of the immune response. Reviewer of research projects in Brazil
Clinical Diagnostics, Immunoassay Product Development, Clinical Toxicology
Expert has two major areas of Expertise: 1) He has been involved in all aspects of In Vitro Diagnostic Immunoasasy and Clinical Chemistry Product Development Including Laboratory Research and Development, Transfer to Manufacturing, Documentation to meet QSR including Design History,…
Acute Wound Healing, Animal Models, Re-epithelization, Wound Infection, Burn Wound Healing, Bacteria
Expert and her mentor, David Taplin were the first to identify flower water as a potential source of hospital acquired bacterial infections. She also worked on and helped develop a medium that has a color indicator to detect dermatophytes. She…
Microbiology, Infection, Infection Control, Occupational and Hospital Hygiene, Biohazards, and Needlestick
Expert offers a highly valued research-driven consultancy specializing in healthcare, environmental, and occupational microbiology, waste management, and bio-safety. With a strong science-based research record in these areas, and a background in NHS and University Medical Schools, he has over 35…
Clinical Laboratory Testing, Interpretation, Quality Assurance and Reporting.
Expert was trained in clinical chemistry and toxicology and is a Fellow of the American Board of Clinical Chemistry, Academy of Clinical Biochemistry and has over 19 years experience directing clinical laboratories including forensic (drug testing) facilities. Expert has a…