CBE’s experience includes conducting assessments of GxP regulatory compliance, designing compliant GxP systems, remediating non-complaint systems, preparing companies for regulatory inspections and addressing regulatory findings from audits.
- Quality Systems
- GMP Licensing
- Validation
- Audits / Gap Analysis
- Mock Audits
- Supplier Qualification
- GMP and GLP
- FDA/TGA/EMA/PICs/ ISO 13485
- Remediation Strategies
- Computer System Validation