Building or expanding a pharmaceutical facility is a major investment, and success depends on meeting global quality and regulatory standards from the start. Pharmatech Associates, a USP company, has nearly three decades of experience guiding clients from conceptual design through buildout and validation.
We support facilities across all therapeutic modalities — from complex biologics and advanced therapies to small molecules and combination products — helping you prepare for inspection and reach production readiness with confidence.
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: 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
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: 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.
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
22320 Foothill Blvd. Suite 330, Hayward CA 94541
