Sustaining a culture of compliance.
Aragen’s robust quality systems across our various facilities ensure that customers can expect the same quality standards irrespective of location. While a quality leadership team, we firmly believe that quality is everyone’s responsibility. Across our organisation, we focus on quality, operational excellence, and reliable execution to support client programmes.
To meet the standards that our customers have come to expect from us, we:
During Fiscals 2026, 2025 and 2024, Aragen observed 288 audits, comprising 21 regulatory audits and 267 customer audits, with no adverse findings.
Delivering Confidence Through Regulatory Excellence
At Aragen, our quality systems are built around one purpose—helping our customers navigate the world’s most complex regulatory landscapes with complete confidence. Our culture of compliance, proactive quality oversight, and All-Time Inspection Preparedness enable us to support customer programs from early development through commercialization—consistently minimizing regulatory risk at every stage.
A defining example of this commitment unfolded in 2026, when our Unit I facility in Nacharam successfully closed an unannounced US FDA Pre-Approval Inspection (PAI) for a critical New Chemical Entity (NCE) program. The inspection resulted in the receipt of an Establishment Inspection Report (EIR)—with the US FDA accepting our response with zero follow-up queries. For our customers, this outcome speaks directly to the robustness of our quality systems, the depth of our documentation practices, and our team’s ability to perform with precision under the most stringent, real-world regulatory conditions.
This achievement did not stand alone. The successful completion of an EU Qualified Person (QP) inspection in the same year further validated our dual-compliance readiness across US FDA and EMA standards—marking two major regulatory wins in 2026, both closed without a single follow-up query.
Together, these outcomes reinforce what our partners experience every day—a dependable, inspection-ready CDMO that delivers quality, compliance, and execution excellence consistently across the entire product lifecycle.
Aragen doesn’t just keep pace with the world’s highest standards—we are built to perform at them.
To ensure independent and impartial decision making, all our sites have their own quality teams that report directly to the global quality head and CEO. Corporate quality assurance (QA) focuses on developing and enforcing uniform standards across the organization on vendor management, quality control, electronic quality management system, digital initiatives (automation), management reviews, management information services, harmonization of procedures, quality compliance, training, turnaround time and quality by design.
At Aragen, we deliver products that enable our customers to make better health possible. What we do impacts lives, so as an organization, we are deeply committed to the quality, safety and effectiveness of our solutions.
