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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…
General Industrial Hygiene; Toxicology; Laboratory Safety; Hazard Communication; Chemical Hygiene
Expert has worked as a consulting industrial hygienist for 24 years. He is both a Certified Industrial Hygienist (CIH) and a Certified Safety Professional (CSP). He has conducted many detailed compliance evaluations/inspections and has developed helpful code interpretations for clients.…
Applied Accounting, Economics, Financial Analysis, Research, Computer Technology (including Project Evaluation, Historical Credit Risk Assessment, Structured Finance, Restructuring)
Expert has a prestigious 26 years of experience in applied accounting, economic and financial analysis, and research combined with personal computer technology. His major work areas include accounting and financial analysis (including project evaluation, historical credit risk assessment, structured finance,…
Vaccines, IVD, Animal Health, Coronavirus Virus and Vaccine Models
Expert has excelled in the animal vaccine field for over 21 years. He has directed licensing for over 40 U.S. and 55 international registrations for avian, bovine, canine, equine, feline and ovine species. Expert has consulted with the world's leading…
Bioanalytics, Chemistry
As an active contributor in the R&D scientific division of both industry and government for the past 20+ years, Expert has had the opportunity to leverage his strong structure elucidation background from graduate school for application in clinical, and forensic…
Medical Device Quality Assurance and Regulatory Compliance
Expert is a 34-year food, cosmetic, drug, biologic, clinical, medical device, and combination product non-technical quality assurance and regulatory compliance veteran with over 21 years of FDA/ governmental experience as an analyst and level II certified international medical device investigator…
Infectious Disease Diagnostics and Scientific Leadership
I am a computer scientist who built and led bioinformatics teams at Lawrence Livermore National Laboratory (LLNL) from 1978-2018. This included the Human Genome Program (1987-2000) and a pathogen bioinformatics team (2000-2018). My team designed PCR assays, microarrays, and sequencing…
in vitro diagnostic assay designing, development and troubleshooting
Experthas developed and participated in assay development and troubleshooting for variety of target molecules with special skill in development of ELISA on different platforms (spectroscopy, luminescence and electrochemical). He has also acquired very good grasp on nanoparticles based rapid assays.…
Food Safety, Nutrition, Regulatory Matters, Health and Wellness, and Business Strategy
With experience in the public and private sectors, Expert provides advice and guidance on a wide range of topics. She has senior experience in health and wellness, business strategy, product development, regulatory compliance, food safety, quality systems management, supply chain,…
Biomaterials, Biotechnology, Medical Devices, Polymer Chemistry, Biomedical Engineering, Materials Engineering, Healthcare (regulatory), Intellectual Property Strategy
Expert has more than 20 years experience in biomaterials and medical devices, both in industry and as a university professor performing research. His research has a translational focus, so he has conducted numerous pivotal animal studies related to the fields…