Make Manufacturing Quality Measurable.
Accelerate Site Readiness. Speed up Regulatory Approvals.
Regller transforms FDA QMM, CFR Title 21, and global regulatory frameworks into a real-time quality score — helping you monitor quality on real time, qualify sites faster, strengthen ANDA/NDA readiness, and prevent compliance issues before they impact supply.
Prevent Quality Failures Before They Happen.
Build Resilient Supply Chains.
Manufacturing quality is the foundation of reliable access to safe medicine and quality food. Yet today, quality remains subjective, audit-driven, and difficult to scale.
Regller transforms quality into a quantitative, continuously monitored system — enabling faster capacity expansion, stronger compliance, and predictable supply.
What Regller Delivers
Quality = A Number
Measure manufacturing quality using thousands of data points aligned with FDA QMM, CFR Title 21, and ICH Q10. Continuously monitor and improve with AI.
Faster Site Qualification
Accelerate validation and readiness using templated, automated qualification workflows. Expand manufacturing capacity faster.
Accelerated ANDA/NDA/BLA Readiness
Create submission-ready documentation using AI-assisted workflows. Reduce timelines and bring products to market sooner.
The quality gap is costing billions — and millions of lives.
Despite decades of regulation, quality failures still cause drug shortages, recalls, and wasted investments. Each year, life-sciences companies spend over $200B fixing preventable issues.
“When quality fails, patients lose access to medicine. Regller is driving the change.”
2 Billion
People worldwide lack regular access to essential medicines
60%+
Drug shortages caused by manufacturing and product quality problems
85%+
Recalls triggered by quality failures at the manufacturer level
$225B
Cost of quality in the life sciences segment. Food adds far more.
Regller is Raising Global Quality Standards
Regller is helping raise the quality bar for safe medicine. Regller is a next-generation AI-driven SaaS platform transforming how life sciences and food industries measure, automate, and elevate quality. It bridges the gap between point-in-time compliance and continuous quality improvement — helping global manufacturers achieve higher Quality Maturity Levels (QML) and sustained operational excellence.
From Quality Data to Predictive Quality Intelligence
Regller transforms thousands of regulatory questions, FDA inspection trends, and operational quality signals into:
- Quality maturity scores
- Risk heatmaps and roadmaps to improve quality maturity
- Continuous monitoring, AI-driven audits for inspection risk indicators
- Early warning signals for supply disruption
By analyzing documents, systems, and quality data together, Regller enables organizations to prevent quality failures instead of reacting to them.
The Industry Shift
A smarter way to build quality — FDA’s QMM Framework.
The FDA’s Quality Management Maturity (QMM) initiative encourages continuous quality excellence — not just compliance.
The Regller Solution: How It Works
Regller Software Platform brings the QMM vision to life through software that measures, automates, and improves quality maturity — globally. Get started in three simple steps.
01
Assess
Take your first quality maturity assessment. Define scope across sites, functions, and processes aligned to FDA QMM practice areas.
02
Benchmark
Compare maturity scores across sites, products, and peer groups. Identify gaps and prioritize improvement investments with data.
03
Improve
Execute your improvement roadmap. Monitor maturity trends, track corrective actions, and drive continuous quality improvement.
How Regller Platform Delivers
Built on FDA Title 21 and operationalized through FDA QMM, Regller embeds regulatory compliance and quality maturity into a single quality operating system.
Regller Quality Risk to Remedy Solution
Benchmark
Quality Improvement Plan
Measure your quality maturity with the Regller QMM Score — transparent, comparable, and actionable.
Standardization & Automation
AI-Enabled Standardization
Use built-in templates and workflows to standardize, reduce manual effort and ensure consistent quality.
Risk Prediction & Prevention
Continuous Quality Monitoring
AI identifies risks before failures — helping you deliver quality products every time, risk-free.
Site Qualification
Digital Qualification Workflows
Structured digital workflows for equipment qualification, facility validation, and site readiness.
Quality Expert Network
Quality and Compliance Network
Connect with quality and compliance experts for faster, more effective regulatory outcomes and continuous improvement.
How Regller Helps Businesses
01 — Know Your Quality
A global life sciences organization operates multiple manufacturing sites with varying quality practices. Leadership lacks a consistent, objective way to understand quality maturity across sites or to prioritize improvement investments.
Regller Solution:
Regller gives a quality scanner that can exactly tell the current quality status. A dashboard helps identify the critical deficiencies for quick remediation.
02 — Qualify Site with AI Templates
A company is bringing a new manufacturing site online and must ensure GMP readiness while qualifying facilities, utilities, and equipment. Multiple teams create inconsistencies and documentation gaps.
Regller Solution:
Regller Site Qualification standardizes and digitizes qualification activities using a risk-based approach fully aligned with FDA Title 21 requirements, ensuring site qualification is achieved Right The First Time.
03 — Validation Automation
An organization is implementing new systems but lacks sufficient validation bandwidth. Manual CSV processes slow deployment and increase documentation burden.
Regller Solution:
Regller Validation Automation digitizes validation planning, execution, traceability, and approvals using a CSA-aligned, risk-based approach. Teams reduce manual effort while maintaining audit-ready validation.
04 — Risk Prediction and Prevention
An organization continues to experience repeat deviations even after investment in systems and repeated audits but lacks early warning signals to prevent issues before they impact compliance.
Regller Solution:
Regller aggregates quality signals across systems and applies AI-enabled monitoring to identify trends, repeat issues, and emerging risks early — supporting proactive intervention and sustained quality control.
Regller is grounded in two regulatory foundations
THE FOUNDATION: FDA QMM and CFR TITLE 21
FDA Quality Management Maturity (QMM)
A forward-looking framework that evaluates management oversight, process performance, and continuous improvement beyond traditional GMP inspections.
FDA CFR Title 21 (GxP Foundation)
The regulatory backbone of pharmaceutical, biotech, medical device, and food compliance. Regller has decoded Title 21 into structured assessments, audit questions, templates, and validation workflows.
Why Regller?
QMM Made Practical. Maturity Made Measurable.
- Built natively on FDA QMM and Title 21 regulatory foundations
- Works with the principle of knowing where you stand, where you want to reach, and what actions to take
- Designed for predictive, risk-based quality improvement
- Combines assessment, automation, and intelligence in one platform
- Scales across sites, functions, and products globally
- Supports regulators, manufacturers, and consultants
Start Measuring Quality Maturity
We are addressing many challenges:
- Quality maturity is unclear
- Validation takes too long
- Site qualification is manual
- Audits are stressful
- Data sits in many systems
- Risks hide until it’s too late
Regller brings everything into one clean workflow — assessment, automation, and action.
Connect with Regller
Connect with our team to discuss more.