Pharmatech design reviews go beyond architecture, we evaluate facilities the way regulators and drug manufacturers experience them. Drawing over 30 years of CMC, Quality, and GMP manufacturing expertise across FDA, EMA, and other global frameworks, shaped by decades of hands-on support through real-world inspections and facility start-ups, we translate compliance expectations into specific, buildable requirements and align sponsors, A&E teams, and contractors around what “right-first-time” looks like.
Just as importantly, we design with CQV in mind: turning design intent into clear URS/design qualifications and a risk-based commissioning, qualification, and validation strategy that prevents downstream surprises. The result is fewer redesigns, change orders, and qualification failures, accelerating the facility development cycle and maximizing capital efficiency. By reaching a stable state of control faster, sponsors get to reliable production sooner, reducing overall business risk while improving payback timing and strengthening investment returns (IRR and MOIC), not just compliance.
Examples of services include:
• Manufacturing and packaging facility design review
• GMP facility, utility, and equipment startup
• Validation planning and program management
• Development and execution of CQV protocols
Facility readiness is critical to bringing any therapy to market. Pharmatech provides expert design reviews and Commissioning, Qualification, and Validation (CQV) services to ensure your facility complies with cGMP standards.
Our consultants collaborate closely with regulators worldwide, identifying design gaps early and mapping out practical, risk based compliance roadmaps. We also provide end to end CQV management including master plans, SOPs, lifecycle documentation, and staff augmentation.
Case Study: Design Review Drives Global Compliance
A client with both pilot and commercial sites intended for the US, China, and EU engaged Pharmatech for a comprehensive facility design review. We recommended targeted design changes, created qualification documentation, and developed cost benefit analyses. The client received a compliance roadmap that ensured inspection readiness across multiple regions.
Modern GMP manufacturing relies on coordinated infrastructure and well trained teams. Pharmatech supports validation across enterprise systems, equipment, utilities, and processes, helping you keep operations inspection ready and efficient.
Our services range from ERP and LIMS validation to maintenance program refinement and supply chain control. We bring leadership experience from engineering, operations, and quality to ensure alignment across functions.
Case Study: CQV Planning Enables Clinical Expansion
A client preparing late stage clinical programs needed to expand into a multi building site. Pharmatech led commissioning and qualification for utilities and systems, conducted Part 11 assessments, and developed validation risk analyses and CQV protocols. The outcome was a compliant facility that advanced programs on schedule despite shifting construction and regulatory demands.
When budgets and timelines are tight, execution must be phase appropriate and risk based. Pharmatech develops project charters and master execution plans that balance regulatory requirements with business priorities.
We facilitate alignment across engineering, construction, and quality teams, ensuring progress toward GMP readiness without unnecessary delays or cost.
Case Study: From Design to GMP in One Year
A cell and gene therapy client required a complete refurbishment and buildout under aggressive timelines. Pharmatech validated more than 125 systems, managed FAT and SAT reviews, authored all CQV documentation, and oversaw execution from design through release. Within one year, the facility achieved GMP production readiness.
Whether constructing a new facility or expanding existing capabilities, Pharmatech Associates provides the strategy and execution to meet regulatory standards and accelerate readiness.
Our unique approach can help your company navigate the complexities of launching a drug, biologic or medical device into multiple markets. The first step? Connecting. Simply fill out our form and a representative will follow-up shortly.
1.877.787.0177
510.732.0177
Pharmatech Associates, Inc. 9110 Alcosta Blvd. STE H #601 San Ramon CA 94583
