Commissioning, Qualification & Validation
For years, we have been providing comprehensive CQV solutions to Life Sciences organizations worldwide.
End-to-End Validation Lifecycle Support
For years, we have been providing comprehensive CQV solutions to the Sciences organizations worldwide. Our validation experts deliver:
Strategic CQV Planning: Tailored validation approaches for your specific products and processes
Full Protocol Development: From IQ/OQ/PQ to cleaning and computer system validation
On-Site Execution: Hands-on support for on-the-floor validation activities
Data Integrity Management: Rigorous analysis and documentation
Final Reporting: Compliance-ready deliverables for regulatory submissions
CQV Solutions for Equipment & Process Validation
Our expert CQV team partners with clients to develop customized validation strategies through flexible engagement models designed for optimal results:
1. Full Project Model
Deployment of High-Performance Teams (HPT) for turnkey validation solutions.
Comprehensive scope covering:
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End-to-end project management
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Execution of all CQV deliverables
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Development of forecasting tools
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Service demand tracking
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KPI selection and performance monitoring
2. Staff Augmentation Model
Precision-matched CQV specialists from our global talent network.
Dedicated resource management featuring:
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Continuous client communication
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Progress tracking and reporting
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Seamless integration with your team
3. Hybrid Engagement Model
Proven U.S.-based approach combining:
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High-Performance Teams for core validation
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Targeted specialists for specific workstreams
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Flexible scaling from project initiation through completion
Built on our signature Zentrum24 Partnership approach emphasizing trust and collaboration
Our Differentiators
Cross-Sector Expertise
Proven experience across parenteral manufacturing of pharmaceutical interoperates.
Regulatory Alignment
Solutions designed to meet FDA, EMA, and global requirements
Lifecycle Approach
Comprehensive support from initial commissioning through ongoing validation.
Practical Execution
Combining technical excellence with operational reality
Why Clients Choose Our CQV Services
Adaptable Resourcing
Right-size solutions for every project phase
Validation Excellence
100% focus on life sciences CQV
Regulatory Confidence
Compliance with FDA, EMA and global standards
Performance Visibility
Real-time tracking and KPI reporting
Why Choose Us
Parenteral Specialization
Focused expertise in complex modalities (mAbs, vaccines, cell therapies, LNP)
Science-Driven Compliance
Technically-grounded strategies that preempt regulatory challenges.
Global Regulatory Mastery
Proven navigation of FDA, EMA, and 30+ international frameworks.
Therapeutic Breadth
Successful delivery across all medicinal product categories.
End-to-End Solutions
Seamless support from discovery through post-approval commercialization.
Operational Synchronization
GMP-aligned solutions integrated with your quality systems.