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
Services
QMM Assessment Services
Full‑cycle QMM assessment planning, execution, site reporting, cross‑site benchmarking and corporate management reporting for pharmaceutical manufacturers.
QMM Development Services
Strategy, quality management process re‑engineering, policy and SOP development, training, vendor selection and organizational change management to implement QMM principles.
QA/QC and Regulatory Affairs Support (cGMP)
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.
Logistics and Supply Chain Management
Asset and inventory lifecycle management, warehouse operations, medical kitting/co‑packaging, cold chain storage, recall management and records management.
Product Development and R&D Support
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.
Program Leadership and Management Services
Executive advisory, strategic planning, performance management, process improvement, PMO design and implementation, and integrated planning for complex programs.
QMM Assessment Services
Full‑cycle QMM assessment planning, execution, site reporting, cross‑site benchmarking and corporate management reporting for pharmaceutical manufacturers.
QMM Development Services
Strategy, quality management process re‑engineering, policy and SOP development, training, vendor selection and organizational change management to implement QMM principles.
QA/QC and Regulatory Affairs Support (cGMP)
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.
Logistics and Supply Chain Management
Asset and inventory lifecycle management, warehouse operations, medical kitting/co‑packaging, cold chain storage, recall management and records management.
Product Development and R&D Support
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.
Program Leadership and Management Services
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