Dr. Stuart G. Levy
SGL Chemistry Consulting
92 Fairmont St
Arlington, MA 02474
Phone:
(617) 504-3519; (781) 316-2594
E-mail: sglevy@sglchemistryconsulting.com
Web Site: www.sglchemistryconsulting.com
Specialties:
- Organic Chemistry
- Manufacturing
- Pharmaceutical
- CMC
- Stereochemistry
- Development
- Process R&D
- Synthetic route scouting and selection
- Technology transfer
- Formulation development (oral, topical and solution)
- Analytical and chemical process development troubleshooting
Services Offered:
- Expertise in Chemical Development
- Evaluation and optimization of synthetic routes to drug candidates
- Adaptation of discovery chemistry routes for scale-up
- Chemical process development and optimization
- Creation and execution of fit for purpose R&D, production and cGMP manufacturing strategies and plans
- Design of syntheses of stable isotope and radiolabeled molecules for in vivo studies
- Physicochemical characterization
- Solid state chemistry - polymorphism, salt screening and selection
- Sourcing of raw materials, excipients and standards
- Vendor Selection, Engagement and Management
- API, drug product, analytical, custom synthesis, QA and regulatory support
- Creation of requests for proposal
- Definition of scope of work, deliverables and timelines
- Facilitation of performance and completion of work
- Technology transfer - assembly of tech transfer packages, performance of tech transfer to and between vendors and organizations
- Excellent vendor network
- Problem Solving
- Troubleshooting of chemical process development and API manufacture, drug product process development and manufacture, analytical method development
- Leadership of expert teams in the solution of complex technical problems
- Broad, multidisciplinary consultant network
- Assistance with Strategy and Management of Drug Development Programs
- Coordination of CMC activities
- Liaison between technical functions, regulatory, QA; Effective, clear communication across disciplines
- Technical and Regulatory Documentation
- Drafting, review and editing of development reports
- Authorship, review and editing of CMC regulatory documents, including INDs, NDAs, amendments, biowaivers
- Regulatory/QA
- Interpretation and application of FDA and ICH guidances pertaining to CMC development activities
- Practical experience in quality audits and mock PAIs in US, India and Japan
