Gxp Quality Systems
- GMP, GLP, GCP, GDP, GPV, & CLIA Quality System Design, Remediation, and Optimization
- Organizational Design & Effectiveness
- Risk Management
- Data Integrity Assessments, Strategy and Deployment
- Design Control
- Process & IT Validation
- SDLC Program/Cloud Enterprise Systems
- GxP Training
GMP Compliance
- Quality System & Quality Unit Organizational Assessment
- Corporate GMP Compliance, Governance, & Risk Assessment
- Supplier selection, Qualification, & Management
- Mock GMP & Pro-Approval Inspections
- Assistance with Deviation Management & Corrective Actions
- GMP Training
GCP / GLP Compliance
- GCP/GLP Quality System & Quality Unit Organizational Assessment
- Mock Sponsor Inspections
- CRO Qualifications & Selection
- GCP, GLP, & GVP Training
Regulatory Inspection Readiness
- PAI & Inspection Readiness Evaluation & Assessment
- Inspection Management Strategy
- PAI and Inspection Readiness Training