Quality Assurance & GxP Compliance
Comprehensive quality systems ensuring GMP, GCP, and GLP compliance across your pharmaceutical operations
Our Quality Assurance Services
Quality System Implementation
Design and implementation of robust quality management systems aligned with international standards
- Quality Management System (QMS) design
- ISO 13485 and ICH Q10 implementation
- Quality risk management (ICH Q9)
- Change control and CAPA systems
GMP Compliance & Manufacturing
Good Manufacturing Practice compliance for pharmaceutical manufacturing operations
- GMP gap analysis and remediation
- Manufacturing process validation
- Cleaning validation programs
- Equipment qualification (IQ/OQ/PQ)
GCP & Clinical Quality
Good Clinical Practice compliance for clinical trial operations and data integrity
- Clinical quality management plans
- Site qualification and monitoring
- Data integrity and ALCOA+ compliance
- Clinical audit and inspection readiness
Laboratory Quality & GLP
Good Laboratory Practice compliance for analytical and non-clinical testing
- Analytical method validation
- Laboratory qualification and accreditation
- GLP compliance programs
- Stability study management
Audit & Inspection Support
Comprehensive audit preparation and regulatory inspection support
- Internal audit programs
- Regulatory inspection preparation
- Vendor audits and qualification
- CAPA system management
Training & Competency
GxP training programs and competency assessments for your teams
- GxP training curriculum development
- Competency assessment programs
- Technical writing and documentation
- SOP development and maintenance
GxP Compliance Framework
GMP
Good Manufacturing Practice
Ensuring pharmaceutical manufacturing meets quality standards
- EU GMP Guidelines
- FDA cGMP Regulations
- ICH Q7 API Guidelines
- Pharmaceutical Quality System
GCP
Good Clinical Practice
International standards for clinical trial conduct and data integrity
- ICH E6(R2) Guidelines
- EU Clinical Trials Regulation
- Data integrity (ALCOA+)
- Risk-based monitoring
GLP
Good Laboratory Practice
Quality standards for non-clinical laboratory studies
- OECD GLP Principles
- FDA GLP Regulations
- Laboratory accreditation
- Analytical method validation
Quality Risk Management (ICH Q9)
Systematic approach to quality risk management throughout the product lifecycle, enabling enhanced decision-making and continuous improvement.
Risk Assessment
Risk identification, analysis, and evaluation
Risk Control
Risk reduction and acceptance decisions
Risk Review
Risk communication and monitoring
Comprehensive Audit Process
Pre-Audit
- Audit planning and scope definition
- Documentation review
- Team preparation and training
- Mock audit execution
Audit Execution
- Opening meeting and introductions
- System and process evaluation
- Evidence collection and analysis
- Finding documentation
Post-Audit
- Closing meeting and findings presentation
- Audit report preparation
- CAPA plan development
- Follow-up and verification
Quality Technology & Standards
Quality Management Systems
- ISO 13485 (Medical Devices)
- ISO 9001 (Quality Management)
- ICH Q10 (Pharmaceutical Quality)
- 21 CFR Part 820 (FDA QSR)
Data Integrity Standards
- ALCOA+ Principles
- FDA Data Integrity Guidance
- EMA Data Integrity Guidelines
- GAMP 5 (Computer Systems)
Validation Frameworks
- Process Validation (FDA/EMA)
- Analytical Method Validation
- Computer System Validation
- Cleaning Validation
Risk Management Tools
- FMEA (Failure Mode Analysis)
- HAZOP (Hazard Analysis)
- Risk Assessment Matrices
- Control Strategy Development
Achieve Quality Excellence
Partner with our quality experts for comprehensive GxP compliance and continuous improvement