2
Billion
people worldwide lack regular access to essential medicines due to manufacturing quality issues.
Regller is driving the change!
Regller is an AI-enabled quality maturity platform. This quality monitoring and improvement platform designed to help regulated life sciences and food organizations measure, manage, and improve quality maturity while reducing operational and regulatory risk. Built on FDA Quality Management Maturity (QMM) principles, Regller enables organizations to move from reactive compliance to predictive, risk-based quality improvement.
The Regller platform is built using the full FDA Title 21 codes and aligns with FDA QMM principles to ensure quality is delivered Right The First Time.
Our mission is to make global healthcare and food systems safer by helping companies measure and improve quality maturity. We help your teams move from reactive firefighting to predictable, planned quality.
Access to quality food and medicine can increase life expectancy siginificanly
Regller is raising global quality standards for safe medicine and food.
In addition to software, Regller provides expert services including platform implementation, computer system validation (CSV and CSA), GxP audits, inspection readiness, and design-thinking-based quality transformation. Together, Regller software and services help organizations strengthen quality culture, improve inspection outcomes, reduce the cost of quality, and build resilient, enterprise-wide quality systems aligned with global GxP expectations.
We help your teams move from reactive firefighting to predictable, planned quality.
Curated sets
-
Regller QMM delivers structured quality maturity assessments, management review dashboards, and continuous improvement tracking.
-
Validation Automation digitizes computer system validation, CSA-based testing, and qualification workflows with audit-ready traceability and electronic approvals.
-
Site Qualification supports risk-based qualification of facilities, utilities, and equipment, enabling consistent GMP execution and inspection readiness across sites.
-
Risk Prediction and Prevention aggregates quality signals—including deviations, CAPA, audits, and validation data—to identify trends, repeat issues, and emerging risks before they escalate into regulatory findings, recalls, or supply disruptions.
