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.
Pharmaceutical Science; Preformulating, Development, Chemistry, Manufacturing & Control (CMC) Issues; Paragraph IV Hatch-Waxman & Canadian Notice of Allegation
As the development of a pharmaceutical reaches Phase 3, prior to submission of an NDA, method validation is required. Validation is a demonstration of optimization. By demonstrating the capacity of a method within the bounds of validation, optimal conditions for…
Formulation
Pharmaceutical product development, scale-up, commercial manufacturing. Process design, improvements, economic changes. Complex product development, bioavailability, absorption enhancement. Intellectual property analysis and guidelines for alternative strategies. Sourcing, quality, regulatory CMC guidance. Proven track record of 30 years in effective product development…
Polymer (Plastics, Composites, Fibers, Nanotechnology) Engineering & Science, Including Formulation, Processing, Characterization, Structure-Property Relationship, Nonwovens, and Coatings
As a professional engineer and scientist, in addition to holding BS (2001), MS (2004), and Ph.D. (2016) in polymer (plastics, composites, & fibers) engineering & science, he has more than 17 years of work experiences in the relevant fields at…
Metal Packaging (Beverage Cans, Aerosol Cans, Food Cans, etc.), Design, and Innovation
Expert co-founded a management consulting firm for packaging where he is a Principal. He covers all types of packaging, primary, secondary & tertiary, and he specializes in metal packaging (beverage cans, food cans, aerosol cans, general line cans, etc.). Expert…
Equipment Validation
Experienced pharmaceutical process engineer with demonstrated ability in managing, supporting, and formulating in a dynamic environment. EQUIPMENT EXPERIENCE Ackley Imprinter Glatt - GPCG-1, GPCG Pro-5, VG Pro 65, Midi Glatt, VG-25, Glatt SKS-100 valves. Korsch - XL400WIP,…
Hepatology Nonalcoholic Fatty Liver Disease (NAFLD), Nonalcoholic Steatohepatitis (NASH) Liver Disease, Pharmacovigilance, Drug Development- Drug-Induced Liver Injury Hepatotoxicity
Expert has been a hepatologist since 1988. She was in a solo practice devoted to treating and evaluating patients with liver disease until 2009 at which time she became Director of Hepatology. During that time she served as a consultant…
Biological Systems Engineering
- Biological systems engineer, marine biologist, ecologist, environmental scientist, and biotechnologist with commercial operations and research experience leading, designing, developing, executing, and managing projects. - Innovative applied scientist and engineer with a multitude of skills, a patent portfolio, over 20…
Medicinal Chemistry and Pharmaceuticals
Expert's services have been retained in a high-profile ANDA case against Pfizer. Expert was deposed and participated in pretrial preparation. He has recently provided expert witness consulting services in a case for a nutraceutical company, where he was deposed and…
Pharmaceuticals: Formulations, Injectables, Topicals, Analgesics, Pharmaceutical Analysis
CORE SKILLS Instrumentation skills. APIs/preformulation: X-ray diffraction; Raman spectroscopy; HPLC (potency, degradants, purity, linearity, accuracy, precision, LOQ, LOD) with detection via UV-Vis, fluorescence, and conductivity; content uniformity, dissolution/elution incl. sustained- and immediate release formulations, paddle wheel apparatus; forced degradation incl.…
Pharmaceutical Development
Expert is a former FDA Review Chemist, with > 39 years of career experience in pharmaceutical R&D, Quality Operations and Regulatory Affairs. For 25+ years as a consultant in his own pharmaceutical development advisory firm, Expert has furnished clients with…