Design, CQV and Validation Services
Pharmaceutical, cosmetic and medtech manufacturers need facilities, systems and processes that can be validated and defended during any GMP audit. Many projects fail because early design documents do not support qualification or because contamination risks are not identified at the right time. Our Design, CQV and Validation service provides strategic support from concept through basic and detailed design to help you make the right decisions before problems appear.
With our involvement, cGMP compliance and contamination control best practices are built in from the beginning. This strengthens your qualification programme and gives you a facility that is easier to validate, easier to operate and easier to defend during inspections.
Strategic Support From Early Design
We represent your interests during early design so your documents, flows and decisions support a successful validation phase.
We help you create and review:
• User Requirements Specifications
• Technical specifications and design documents
• Material, personnel, waste and equipment flows
• CIP and SIP strategies and cleaning philosophies
• Clean utility and water system designs
• Equipment design intent and lifecycle needs
Our work ensures contamination control principles are embedded at the earliest stage. This reduces risk, avoids redesign and prepares your facility for smooth qualification.
Risk-Based Qualification Throughout the Project
A strong qualification programme focuses on risks that matter to product quality. We support you through DQ, IQ, OQ and PQ to ensure your facility, utilities and processes are verified in a structured and compliant way.
Our support helps you:
• Confirm that design choices align with GMP and Annex 1
• Define qualification scopes based on process and contamination risk
• Produce consistent and audit-ready validation documents
• Execute qualification activities efficiently
• Demonstrate that your process is ready for routine operation
This approach protects your schedule and strengthens your inspection readiness.
Documentation Ready for Any GMP Audit
Validation documentation must tell a clear and defensible story. We help you build validation packages that meet EU GMP, FDA CFR and ISO expectations. This reduces stress during inspections and gives auditors confidence in your quality system.
Value for Your Project
• Stronger startup and fewer delays caused by design or documentation gaps
• A facility designed for compliance and contamination prevention from day one
• Faster qualification and a more predictable CQV phase
• Clear traceability from URS to PQ
• Reduced exposure to audit findings and regulatory risk
• A smoother transition from project delivery to routine commercial operation
Clients gain a facility that is compliant, efficient and validated on a solid foundation of cGMP and contamination control expertise.