CQV Leadership

Audit-Ready. Production-Ready. Aligned from Day One.

Commissioning, Qualification, and Validation (CQV) is where capital projects are judged—not just by regulators, but by your operational team. Agile Advisors leads CQV with a sharp focus on compliance integrity, execution control, and startup velocity. We bridge construction, engineering, and QA to deliver validated systems and auditable documentation that withstand inspection and support commercial production.

Whether supporting a greenfield facility, new fill/finish suite, or retrofitted process train, our CQV leaders embed early to shape strategy, manage risk, and drive flawless execution through IQ/OQ/PQ.

Connect with a CQV Expert

What We Deliver

Strategic CQV Planning

Early-phase CQV roadmap aligned to cGMP milestones and business timelines
Integration of FAT/SAT, construction turnover, and qualification workflows
Development of master planning documents and traceability matrices

Cross-Functional Coordination

Interface with engineering, operations, QA, and validation
CQV support aligned with tech transfer, SOPs, and training milestones
Support for GMP-readiness walkthroughs, mock audits, and PAI strategy

Protocol Development & Execution

Authoring, review, and execution of IQ/OQ/PQ protocols to meet FDA and EMA expectations
Real-time management of execution teams, vendor support, and documentation control
Deviation management, resolution, and audit trail integrity

Turnover to Production

Verification of system functionality and documentation completeness
Final punchlist closure and QA acceptance
Oversight through PV and handoff to operations

OUR VISION

Why It Matters

Too often, CQV is treated as the final task on a capital project checklist—delaying production and exposing gaps. Agile Advisors treats CQV as a strategic lever for compliance and speed. We’ve led CQV for new product introductions, major aseptic expansions, and formulation suite upgrades—managing qualification efforts for 5+ fill lines on programs exceeding $300M in value.

We don’t just execute protocols—we lead programs to successful startup and inspection-readiness.

When to Engage Agile Advisors

CQV scope is fragmented across vendors and lacking coordination
Internal teams need supplemental leadership or technical expertise
Deviation volume is high or risk of audit findings is rising
You need an integrated plan that connects CQV with capital and compliance deliverables