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Clinical Diagnostics, Life Sciences and Medical Devices
Expert has over 30 years of experience in clinical diagnostics, life sciences, and medical devices. Expert is the President of a health care consultancy. He has experience in the identification, acquisition, and commercialization of new businesses and products in the…
Clinical Development, Regulatory Development
Following more than 25 years in the pharmaceutical industry (Big Pharma, Contract Research Organizations, Small Pharma), Expert has accumulated experience from several hundred clinical studies, primarily in Phase I/Phase II ("First-in-Human", "proof-of-concept") across most therapeutic areas (Metabolic, Infectious, Oncology, Urology,…
Assay Development, Bioanalytical Chemistry, Validation, Intellectual property
The expert has extensive experience writing proposals, résumés, cover letters, CVs, grant applications, provisional patent applications and technical publications. Additionally the expert has experience in the areas of assay development, bioanalytical chemistry and food and agricultural products testing.The expert has…
Genomics and Biomarkers
Expert is a solutions-oriented business development and scientific professional with broad experience in the development of genomics and proteomics tools and the applications of these tools in research and drug discovery. Expert has a BA in Biology from Clark University.…
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…
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…
Diagnostic Reagents Formulations & Trouble shooting; Disinfectants and Hand Sanitizers; Stains
Mr . Expert has aquired efiiciancy in the field of formulating various clinical chemistry analytical kits. He had more than 5 yrs of experience in designing and setting various products manufacturing units with complete transfer of technology. He is post…
Dermatology – General, Surgical, Cosmetic & Laser Surgery
Expert J. Expert is a board certified fellow of the American Academy of Dermatology with expertise in many areas of medical & cosmetic dermatology. She is a lecturer at national meetings and is an instructor for three residency programs in…
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,…
Near Infrared Spectroscopy, Multivariate Analysis, Pharmaceutical Analysis, (GMP)
Expert is an internationally recognized expert in pharmaceutical analysis, regulatory compliance, laboratory management, design quality, and process analytical technology using spectroscopic methods, including near-infrared and multivariate analysis. Nineteen years of industry experience with increasing responsibility and five years of policy…