Api Manufacturing Expert Witnesses
Api manufacturing 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 api manufacturing. The api manufacturing 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
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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...
