Strong quality operations are the backbone of successful pharmaceutical programs. Whether you are a start-up preparing for IND filing or an established company scaling toward commercial launch, your quality management systems must meet evolving expectations and stand up to regulatory scrutiny. Pharmatech Associates, a USP company, partners with you to design, assess, and remediate systems that ensure quality is built in from the start. Our team applies quality by design principles so your operations remain compliant, inspection ready, and positioned for growth
Building and maintaining a robust QMS requires more than compliance. It demands insight into global regulations, teams that understand their role in quality, and a strategy that adapts as your program grows. We work with you to identify gaps, create a clear roadmap, and establish documentation, SOPs, and training that give you confidence when regulators arrive.
What you gain:
Case Study: Merging Divergent QMSs Into One Companywide Solution
After multiple acquisitions, a client faced overlapping systems and inconsistent practices. We mapped processes across all sites, identified redundancies, and created a unified QMS.
Impact for the client:
✔ Regulatory alignment strengthened
✔ Unified QMS easier to maintain and scale
✔ Improved usability and quality ownership across teams
From eQMS and LIMS to ERP platforms, digital systems are essential to a modern quality strategy. We help you evaluate, select, and implement the right systems based on your operational needs and regulatory requirements.
Our support includes requirements definition, vendor selection, integration oversight, computer system validation, and compliance checks to keep your IT infrastructure inspection ready
Case Study: Smooth and Speedy Site Transition Avoids Cost Overruns
During a site divestiture, a client needed to transition all quality and laboratory systems quickly. We managed system evaluation, decommissioned legacy platforms, and implemented new LIMS and eQMS solutions.
Impact for the client:
✔ Transition completed on schedule
✔ Legacy cost exposure avoided
✔ Fully validated, compliant IT environment
Quality systems must evolve as your program moves from clinical through commercial stages. We help you adapt strategies, facility qualifications, and control systems at each milestone so compliance never becomes a bottleneck
Case Study: QMS and cGMP Facility Renovation for Two Major Markets
A stem cell biotherapeutics company needed to convert a 44,000 square foot space into a compliant site for both US and EU markets. We led facility qualification, equipment validation, and QMS development.
Impact for the client:
✔ Facility fully compliant with dual market requirements
✔ QMS established for long-term growth
✔ Site inspection ready for clinical and commercial use
A trusted QMS partner helps you avoid costly setbacks and stay inspection ready at every stage of development. Pharmatech Associates designs, assesses, and implements quality strategies that support compliance, accelerate milestones, and scale with your growth
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
