Quality Management
- Quality Oversight and Strategy
- Risk Management
- CAPA and Escalation
- QA support of Clinical Operations
- Expert GCP Auditing
- Inspection Readiness and BIMO Support
Process Improvement
- Gap Analysis
- Creation and Revisions of SOPs
- Project Management
- Document Control and Records Management
- Process training and training content
- Compliance with regulations and quality systems
Process Improvement
- Gap Analysis
- Creation and Revisions of SOPs
- Project Management
- Document Control and Records Management
- Process training and training content
- Compliance with regulations and quality systems
Vendor Management
- Audit Schedules and Plans
- Vendor Risk Assessment
- Escalation and Metrics
- Vendor Audits of GCP/GMP vendors such as CROs, Electronic Solutions, Clinical Operations, CORE Labs, Production, and Manufacturing