Quality and Compliance – Build, Assess, and Remediate

Bringing therapies to patients requires more than a regulatory strategy, it requires a phase-appropriate quality and compliance foundation. Done right, it enables speed in two ways: faster progression to filings and launch, and faster day-to-day execution once operations begin, while maintaining inspection readiness through defensible decision-making and auditability. Pharmatech combines over 30 years of drug development, CMC, and GMP execution experience to help sponsors build the right level of Quality System for where the program is today, then scale it intelligently as the pipeline matures.

We focus on people, processes, and tools: clarifying roles and governance, aligning resourcing to critical quality activities, and implementing pragmatic, fit-for-purpose systems such as, deviations/CAPA, change control, training, supplier quality, and data integrity, that support submissions and day-to-day operations. This reduces the total cost of quality by preventing avoidable failures and shortens the time and effort to resolve issues when they occur, lowering the cost of poor quality without creating unnecessary bureaucracy. The result is fewer agency surprises, less rework, faster progression to key milestones, and lower regulatory risk, because compliance is supported by auditable, repeatable processes, day in and day out.