About

Regller LLC is an AI-first quality intelligence software company headquartered in Princeton, New Jersey. Regller helps FDA-regulated life sciences companies make quality measurable, continuously monitorable, and actionable across manufacturing, laboratories, suppliers, validation, audits, and regulatory operations.

At the center of the platform is Regller QualityTwin™, which continuously analyzes thousands of quality and operational signals across 600+ workflows and converts them into a live, transparent quality score. Regller combines internal company data with regulatory intelligence, including more than 262,000 FDA Form 483 observations mapped to regulatory requirements, to help organizations identify emerging risks, benchmark performance, and focus improvement efforts before problems affect product quality or supply.

Regller's purpose-built AI solutions support quality intelligence and FDA Quality Management Maturity (QMM), audit and inspection readiness, validation and CSA/CSV, laboratory operations, manufacturing and batch review, and supplier/CDMO quality management. The platform can work with existing QMS, LIMS, MES, ERP, document management, and other enterprise systems rather than requiring organizations to replace their current technology investments.

Regller is designed specifically for regulated GxP environments. Its private, validated AI architecture enables organizations to apply AI to regulated workflows while maintaining human oversight, traceability, data control, and regulatory compliance.

Unlike traditional quality systems that primarily record events after they occur, Regller is designed to create a continuous intelligence layer across quality and operations. Leaders can move from enterprise-level quality performance to sites, functions, workflows, assets, and supporting evidence—providing a common view of where quality is strong, where it is changing, and where intervention may be needed.

The business objective extends beyond compliance. By identifying quality risk earlier and improving execution across regulated operations, Regller helps companies protect batches, accelerate release, reduce in-process inventory, strengthen supply continuity, and protect revenue.

Regller's mission is to improve patient access to medicines through better quality—helping life sciences organizations move from point-in-time compliance toward continuous quality maturity.