A scientific and management consulting provider with expertise in drug development R&D, drug manufacturing, stockpiling and distribution, quality assurance, and regulatory compliance. Our approach is informed by our experience leading the FDA QMM Pilot for Foreign API Manufacturers and complemented by the collective experience of SMEs who have extensive past affiliation with Big 4 Global Management Consulting firms, National Regulatory Authorities, Biologics and Small Molecules Drug Substance/Drug Product companies and Medical Device manufacturers.
- Assessment Planning and Communication
- Assessment Execution
- Site Assessment Reporting
- Cross-Site Benchmarking
- Corporate Management Reporting
- Strategy and Planning Support
- Site Management Process Re-engineering
- Strategy and Planning Support
- Quality Management Process Re-engineering
- Legal, Quality, and Regulatory Consulting
FDA engaged Shabas through a competitive selection process as a prime contractor to lead the QMM Pilot for API Manufacturers (non-US). Eight API manufacturers from South America, Europe and Asia volunteered for this initiative. Under FDA’s guidance, Shabas conceptualized, developed and administered a QMM Assessment tool specifically designed for facilitated assessment of the API Manufacturers.
- The Shabas team developed an innovative assessment framework and a detailed analytical tool by leveraging insights from pharma and other industries that encompassed FDA-suggested practice areas and topics.
- The tool was administered virtually to the participating sites (with FDA as a silent observer) via facilitated assessment and results communicated to them (including cross-site benchmarking) using automated data analysis and creative reporting mechanisms.
