Expert Directory
Having an expert witness or consultant at your side can help you navigate complex situations with confidence. These professionals understand your industry and excel at conveying crucial information, whether in a courtroom or a consulting environment. At Intellex, we have experts in over 30,000 areas in our database. We enable you to partner with an individual who has the knowledge, educational background, and relevant experience to support your needs effectively.
Utilize our expert finder tool to handpick the ideal mentor or consultant for your specific application.
Transdermal Development Including INDs, ANDAs, NDAs, MAAs, CMC, Preclinical, Clinical, Bioequivalence
I have been involved in transdermal product development for 15 years and have spearheaded the development of quality control, quality assurance, regulatory affairs and clinical research departments. Among my activities are: 1. Designing preclinical, clinical and bioequivalence studies. 2. Filing…
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,…
Biotechnology & Pharmaceuticals: Drug Development, Due Diligence, Strategy, Finance, Market Analysis
With an MD-PhD, clinical training, ten years of experience analyzing and investing in companies developing drugs, ex[erience as a CEO of both private and public biotechnology companies, Expert has seen the drug and biotechnology industries from many angles. As an…
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…
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.…
Pharmaceutical Formulation, Drug Delivery, CMC, NDA, and Formulation Patents
Expert has developed multiple immediate release and modified release oral formulations at ALZA Corporation and at Transcept Pharmaceuticals. Many of these formulations have been commercialized including Invega (OROS paliperidone) and Exalgo (OROS hydromorphone). Recently, Expert was instrumental in developing a…
Competitive Intelligence from Primary Sources in Pharmaceuticals, Diagnostics, and Medical Devices.
•Business research and development professional with a successful record targeting and developing Fortune 500 clients. •Founded pharmaceutical and information technology business intelligence firm and served as Business Development & Research Director for 15 years. •Expertise assessing the unique challenges facing…
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…
Medical Statistics, with a special interest in Evidence Synthesis and Meta-Analysis
Expert (R) Expert has 30+ years experience as an academic medical statistician. His areas of interest and expertise include clinical trial methodology; he was a member of the UK medicines regulatory body, The Committee on Safety of Medicines. He has…