Shabas Solutions LLC
Consulting firm (Virginia, USA) providing scientific, technical, regulatory, quality, logistics, and program management services to government and pharmaceutical industry clients. Core offerings include Quality Management Maturity (QMM) assessment and development, cGMP QA/QC and regulatory support, product development and R&D support for small molecules and biologics, medical logistics and supply‑chain operations, and program/PMO advisory services.
Industries
N/A
Nr. of Employees
small (1-50)
Services
Full‑cycle QMM assessment planning, execution, site reporting, cross‑site benchmarking and corporate management reporting for pharmaceutical manufacturers.
Strategy, quality management process re‑engineering, policy and SOP development, training, vendor selection and organizational change management to implement QMM principles.
Quality assurance and control support for receiving, stockpiling and distribution operations including QC inspection and release, supplier audits, equipment qualification, CSV and regulatory audit support.
Asset and inventory lifecycle management, warehouse operations, medical kitting/co‑packaging, cold chain storage, recall management and records management.
Life sciences consulting including medical affairs, scientific staffing, immunoassay development/validation, sample management, clinical trial support, and CMC/process development for small molecules and biologics.
Executive advisory, strategic planning, performance management, process improvement, PMO design and implementation, and integrated planning for complex programs.
Full‑cycle QMM assessment planning, execution, site reporting, cross‑site benchmarking and corporate management reporting for pharmaceutical manufacturers.
Strategy, quality management process re‑engineering, policy and SOP development, training, vendor selection and organizational change management to implement QMM principles.
Quality assurance and control support for receiving, stockpiling and distribution operations including QC inspection and release, supplier audits, equipment qualification, CSV and regulatory audit support.
Asset and inventory lifecycle management, warehouse operations, medical kitting/co‑packaging, cold chain storage, recall management and records management.
Life sciences consulting including medical affairs, scientific staffing, immunoassay development/validation, sample management, clinical trial support, and CMC/process development for small molecules and biologics.
Executive advisory, strategic planning, performance management, process improvement, PMO design and implementation, and integrated planning for complex programs.
Expertise Areas
- Quality Management Maturity (QMM) consulting
- Regulatory compliance and cGMP QA/QC
- Pharmaceutical product development and CMC
- Assay development and analytical validation
Key Technologies
- Quality Management Maturity (QMM) assessment protocols
- Computerized system validation (21 CFR Part 11)
- Cold chain temperature monitoring
- Immunoassay development and validation
News & Updates
Article on early adoption and practical considerations for executives relating to FDA Quality Management Maturity program.
Federal Register notice inviting qualified pharma companies to participate in next round of QMM protocol assessment.
Paper discussing approaches to incorporate digital health technologies into clinical trial design and monitoring.
Served as prime contractor to conceptualize, develop and administer a QMM assessment protocol for non‑US API manufacturers under FDA guidance, including virtual facilitated assessments and automated analysis/reporting.
Delivered QA/QC services for receipt, inspection and disposition of medical supplies in a government‑owned, FDA‑registered logistics facility during emergency response operations.
Article on early adoption and practical considerations for executives relating to FDA Quality Management Maturity program.
Federal Register notice inviting qualified pharma companies to participate in next round of QMM protocol assessment.
Paper discussing approaches to incorporate digital health technologies into clinical trial design and monitoring.
Served as prime contractor to conceptualize, develop and administer a QMM assessment protocol for non‑US API manufacturers under FDA guidance, including virtual facilitated assessments and automated analysis/reporting.
Delivered QA/QC services for receipt, inspection and disposition of medical supplies in a government‑owned, FDA‑registered logistics facility during emergency response operations.