Our services
Audit & Compliance
Assurance Built Into the System.
We provide risk-based audit, compliance and quality support designed to assess systems, identify gaps, strengthen controls and maintain sustained readiness across pharmaceutical operations.
Capabilities
AUDIT & COMPLIANCE
QUALITY SYSTEM ASSESSMENT
- Quality Management System Assessment
- GxP Compliance Assessment
- Process Assessment
- Documentation Review
- Governance Assessment
- Quality Maturity Assessment
- System Effectiveness Review
GVP & PV COMPLIANCE
- GVP Compliance Assessment
- PV System Assessment
- PSMF Assessment
- PV Process Review
- QPPV System Assessment
- ICSR Process Assessment
- Aggregate Reporting Assessment
- Signal Management Assessment
- RMP / RMM Assessment
AUDITS & ASSESSMENTS
- Internal Audits
- GVP Audits
- GxP Audits
- Vendor Audits
- Partner Audits
- Service Provider Assessments
- Supplier Qualification Audits
- Remote Audits
- On-Site Audits
- Follow-Up Audits
GAP ASSESSMENT & REMEDIATION
- Regulatory Gap Assessment
- Process Gap Assessment
- Documentation Gap Assessment
- Compliance Gap Identification
- Risk Prioritisation
- Remediation Planning
- Remediation Tracking
- Effectiveness Assessment
CAPA & DEVIATION MANAGEMENT
- CAPA Development
- CAPA Management
- Root Cause Analysis
- Deviation Management
- Investigation Support
- Corrective Actions
- Preventive Actions
- Effectiveness Checks
- CAPA Tracking
- CAPA Closure
CHANGE & QUALITY RISK MANAGEMENT
- Change Control
- Quality Risk Assessment
- Risk Identification
- Risk Evaluation
- Risk Mitigation
- Impact Assessment
- Change Implementation
- Change Effectiveness Review
- Risk Monitoring
INSPECTION READINESS
- Inspection Readiness Assessment
- Mock Inspections
- Inspection Preparation
- Documentation Readiness
- Evidence Compilation
- Interview Preparation
- Inspection Room Support
- Response Coordination
- Commitment Tracking
- Post-Inspection Support
TRAINING & QUALITY CULTURE
- GxP Training
- GVP Training
- SOP Training
- Audit Awareness
- Inspection Readiness Training
- CAPA Training
- Quality System Training
- Role-Based Training
- Training Effectiveness Assessment
VENDOR & THIRD-PARTY OVERSIGHT
- Vendor Qualification
- Third-Party Risk Assessment
- Vendor Audits
- Service Provider Oversight
- Quality Agreements
- Responsibility Assessment
- Performance Monitoring
- Compliance Review
- CAPA Follow-Up
Discuss your audit & compliance requirements
Tell us what needs assessing or preparing for inspection, and we will scope the right review.