Page 8 - ALMExperts 2025 New England Directory

Stuart G. Levy, Ph.D.
Principal, SGL Chemistry Consulting

92 Fairmont St . (781) 316-2594
Arlington, MA 02474 (617) 504-3519 (cell)
Email: [email protected]
SERVICES OFFERED:

 Expertise in Chemical Development
o Evaluation and optimization of synthetic routes to drug candidates
o Adaptation of discovery chemistry routes for scale-up
o Chemical process development and optimization
o Creation and execution of fit for purpose R&D, production and cGMP manufacturing strategies and
plans

o Design of syntheses of stable isotope and radiolabeled molecules for in vivo studies
o Physicochemical characterization
o Solid state chemistry – polymorphism, salt screening and selection
o Sourcing of raw materials, excipients and standards
 Vendor Selection, Engagement and Management

o API, drug product, analytical, custom synthesis, QA and regulatory support
o Creation of requests for proposal
o Definition of scope of work, deliverables and timelines
o Facilitation of performance and completion of work
o Technology transfer - assembly of tech transfer packages, performance of tech transfer to and
between vendors and organizations
o Excellent vendor network
 Problem Solving
o Troubleshooting of chemical process development and API manufacture, drug product process
development and manufacture, analytical method development
o Leadership of expert teams in the solution of complex technical problems
o Broad, multidisciplinary consultant network
 Assistance with Strategy and Management of Drug Development Programs
o Coordination of CMC activities
o Liaison between technical functions, regulatory, QA; Effective, clear communication across
disciplines
 Technical and Regulatory Documentation
o Drafting, review and editing of development reports
o Authorship, review and editing of CMC regulatory documents, including INDs, NDAs, amendments,
biowaivers
 Regulatory/QA

o Interpretation and application of FDA and ICH guidances pertaining to CMC development activities
o Practical experience in quality audits and mock PAIs in US, India and Japan