GMP Facility Startup
Shaping the Next Generation of GMP Facilities
Guiding you through the complexities of starting up GMP-compliant facilities efficiently and effectively.
CQV Master Scheduling
We build integrated Commissioning, Qualification, and Validation (CQV) master schedules that align technical deliverables with project milestones and business objectives. Our detailed, risk-based plans drive efficiency, minimize bottlenecks, and accelerate critical-path activities—helping you achieve facility readiness and regulatory submissions faster, without compromising quality or compliance.
Validation Master Planning
Outdated validation strategies can lead to higher maintenance costs and increased regulatory risk. Our team develops comprehensive Validation Master Plans (VMPs) that clearly define scope, core principles, and a lifecycle approach tailored to your facility, equipment, operational technology, and processes. Backed by decades of experience, we understand the hidden costs and common pitfalls—and help you avoid them. When you partner with us, we ensure your VMP aligns with current regulatory expectations—including ASTM E-2500, EU Annex 1, Annex 11, and Annex 15; ICH Guidelines, FDA guidance for industry; and the latest best practices from ISPE, PDA, and others. Our VMPs provide a practical, risk-based framework that enables efficient execution, effective change control, and sustained compliance—delivered in the most streamlined and cost-effective way possible.
Process Closure Risk Assessment
When implementing an aseptic process, ensuring that your facility, equipment, and process design adequately mitigates contamination risks at points of product exposure or closure is critical. We support your process closure strategy through structured, science-based risk assessments that evaluate the integrity of closed systems, single-use technologies, and aseptic operations. Our approach helps you identify potential failure points, justify design and procedural controls, and align with regulatory expectations for contamination prevention. Whether you’re adopting new technology, responding to regulatory feedback, or working toward Annex 1 CCS compliance, our assessments provide the clarity and confidence you need to move forward with peace of mind.
Data Integrity Risk Assessment
Deficiencies in data integrity can lead to serious regulatory consequences. If you're preparing for an inspection, upgrading GxP systems, managing legacy data, or addressing past findings, we can help. Our Data Integrity Risk Assessments follow FDA, MHRA, and PIC/S guidance and are built around ALCOA++ principles. We evaluate your systems, processes, and data flows to identify vulnerabilities, prioritize remediation, and implement practical controls. Whether supporting GMP operations, labs, or IT/OT environments, we help you strengthen compliance and protect the integrity of your data lifecycle.
CQV Service Delivery
Whether you're launching a new facility, installing new technology, or conducting periodic reverifications, we understand the pressure to get it right—and on time. Many clients turn to us when internal teams are stretched, timelines are tight, or they simply need more boots-on-the-ground. Our experienced CQV professionals provide end-to-end services across commissioning, qualification, and validation activities. From protocol development and execution to deviation management and project closeout, we deliver the expertise, flexibility, and rigor needed to bring facilities, systems, and processes online—fully compliant and done-done.
