Synthetic Route Selection Expert Witnesses
Synthetic route selection expert witnesses and consultants listed here may be able to form expert opinions, draft expert witness reports, provide expert witness testimony at deposition and/or trial as or serve as consulting (non-testifying) experts on synthetic route selection. The synthetic route selection expert witness listings on this page are typically from fields/areas of expertise such as: Chemistry & Chemicals and Pharmaceutical Research.
Stuart G Levy
CMC/Chemical and Pharmaceutical Development Expert
SGL Chemistry Consulting, LLC
Richmond, California
Pharmaceutical Research, Chemistry & Chemicals
-
API process development, API manufacturing, Solid state and physicochemical characterization, enabled formulation development, drug product development, drug product manufacturing, stereochemistry, process impurity identification, control, synthetic route selection, preformulation, polymorphism
HIGHLIGHTS
• Twenty-eight years of industrial experience in all aspects of chemical development
• Twenty-four years of experience in oversight of external vendors performing chemical development, custom starting material production and API manufacturing, preformulation, formulation development, drug product manufacturing, and all associated CMC activities
• Eighteen years of experience in devising and executing integrated CMC development programs
• Hands-on, results-oriented leadership of CMC development and multidisciplinary teams
• Innovation in the conception of practical synthetic routes to pharmaceuticals, development and implementation of chemical processes for the manufacture of APIs and chemical process troubleshooting.
• Expertise in technology transfer and oversight of chemistry from the research laboratory to kilo labs, pilot plants and multipurpose plants at contract development and manufacturing organizations
• Experience in the development and manufacture o...
