REGLLER · AI-ENABLED SOFTWARE & SERVICES
Quality, scored daily.
Audit-ready, every day.
Quality as a number. From insight to execution. Compliance embedded.
Regller defines quality as a number — RegllerScore™. This is an AI-enabled software-and-services platform for regulated industries. We compute a daily RegllerScore from your own data — SOPs, batch records, lab notebooks, CAPAs, deviations, training, and ERP — and keep every quality data pre-checked, every day. Pharma, biotech, devices, labs, clinical, food. Wherever quality matters.
Built on FDA QMM · 21 CFR · ICH Q10 · GAMP 5 · GxP · EU AI Act
What we deliver
Five offerings. One platform underneath.
An AI-enabled platform that matures your quality — from a baseline number to a continuously improving signal. Compliance follows.
AI Platform
The AI foundation that powers every Regller capability.
- Specialized agents. Doc Reviewer, MFG, QMS, Lab, Training, and ERP — each a specialist on its function, running daily on your operations.
- Works on top of what you have. Modern systems (DMS, QMS, MES, LIMS, ELN, LMS, ERP) — and paper-based systems too. No rip-and-replace, no migration.
- Private AI models. LLMs and ML models trained for FDA-regulated industries — on FDA regulations, CFR Title 21, ICH guidelines, GAMP 5. Your data stays in your environment.
- Validated, Part 11 compliant. Validation package included. GAMP 5 Annex 22, 21 CFR Part 11, ICH Q10, GxP. Single-tenant or VPC. SSO, encrypted everything.
FDA QMM
FDA Quality Management Maturity, operationalized through RegllerScore™ — and every internal assessment, scored continuously.
- FDA QMM, operationalized. Turn the program from a one-time survey into a continuous daily score across all five practice areas — delivered as RegllerScore™.
- Every internal assessment. FDA pre-audit, AI system audit, IT system assessment, infrastructure audit, SOX, GxP, vendor qualification — one engine, one score, every audit.
- Continuous Quality. AI-driven monitoring across sites, functions, assets, and studies. Drift, anomalies, and predictive findings surface before the next audit cycle.
- Benchmark → Improve → Monitor. Three stages, one commitment. Set the baseline, work the plan, keep the signal live — quarter on quarter.
FDA Intelligence
The regulatory and industry intelligence layer.
- Industry analysis. Enforcement trends, top findings, and inspection patterns across your sector.
- Company intelligence. FDA-data-backed view of any manufacturer, supplier, or peer in your network.
- Peer analysis. Quantified position vs. comparable companies — strengths, gaps, and where to invest first.
- FDA inspector intelligence. Inspector profiles, citation patterns, and historical focus areas — what they actually look for.
- Top risk assessments. CFR-code risk heatmap, repeat-finding detection, document risk analysis.
AI Validation
CSA-aligned validation, AI-enabled, end-to-end.
- Validation automation. Pre-built templates and AI-drafted content across CSV / CSA, IQ / OQ / PQ, requalification, change control, tech transfer, equipment, system, cleaning, method, and process validation.
- AI system validation. GAMP 5 Annex 22–aligned validation packages for any AI/ML system used in regulated workflows — including generative and predictive models.
- EU AI Act risk assessment. Risk classification, model card, training-data lineage, evidence pack, continuous assurance.
- CSA-aligned. FDA Computer Software Assurance methodology — risk-based, scaled rigor, scripted vs. unscripted testing applied appropriately. Audit-ready justification on every decision.
AI Consulting
Adopt AI inside regulated workflows. Realize the value.
- Design Thinking for AI. User research, journey mapping, workflow redesign — keep experts in the loop, automate the rest.
- AI Value Realization. ROI modeling, KPI definition, change management, executive enablement — so AI lands as capability, not anxiety.
- Process analysis and AI fitment. Where AI adds value, where it doesn’t, and the 90-day rollout plan that gets you there.
The challenge
Quality is still subjective, audit-driven, and point-in-time.
That is the root cause of supply-chain fragility, drug shortages, and inspection surprises. Over 2 billion people lack consistent access to essential medicines. 60–70% of drug shortages trace back to manufacturing quality. Lab and R&D quality failures delay therapies that patients are waiting for.
Quality leaders today are flying blind between audits. They don’t know their number. They don’t know what’s drifting. And when an inspection hits, the team scrambles. We built Regller to end that pattern.
What we do
Quality intelligence, on top of the systems you already run.
We compute a daily quality maturity score — FDA QMM-aligned — from your own operational data. The same engine grades every internal assessment your organization runs: pre-audit, IT, infrastructure, SOX, AI systems, vendor qualification.
Specialized AI agents (Doc Reviewer, MFG, QMS, Lab, Training, ERP) sit on top of your existing systems — modern and paper-based — and feed one common report. We don’t replace what you have. We make it measurable.
How it works
Benchmark. Improve. Monitor.
Three stages. One engagement model. A number that moves quarter on quarter.
01
Benchmark
Know where you stand.
Objective 1–5 score across all FDA QMM categories. Drillable per site, per function, per asset. Peer benchmark against companies of your size and industry.
02
Improve
Close the gaps with action + automation + templates.
AI-generated action plan mapped to quality-score improvement. Automated qualification packages — equipment, instrument, system, cleaning, CSV — delivered alongside the plan.
03
Monitor
Stay ahead, continuously.
Live aggregation of deviations, CAPA, audits, and inspections. Ongoing peer benchmarking as your score and industry evolve. Proactive risk alerts before findings, recalls, or drift.
Outcomes you will measure
What changes in the first cycle.
5×
Faster
Issue identification over manual execution.
80%
Effort & Cost
Reduction across quality, validation, and audit cycles.
50–60%
Productivity
Gain across quality, lab, and regulatory teams.
Always
Inspection Ready
Continuous audit posture across every standard.
Who we serve
Wherever quality matters.
If your function is held to a standard and audited against it, Regller scores it and keeps it audit-ready.
Standards native
Aligned to the frameworks your function is held to.
Partners & affiliations
Built with leaders in regulated AI and biomanufacturing.
A Microsoft ISV Partner. An active member of the BioMaP Consortium and the Rapid Response Partnership Vehicle (RRPV).
Why now
Compliance gets you to 3. Regller gets you to 5.
A clean cGMP inspection gets you to 3 on FDA’s 5-point maturity scale. The next two points — where the differentiator and the business value live — are what Regller was built for. KPIs, continuous monitoring, predictive loops, automated qualification packages, and a score that actually moves quarter on quarter.
Featured insights
Related reading.
Article
What is FDA Quality Maturity Model (QMM)?
The framework FDA is using to push the industry past point-in-time compliance.
Article
How quality maturity prevents drug short supply.
Quality maturity is the supply-chain resilience metric most CFOs aren’t looking at yet.
Article
What FDA’s first QMM scorecard tells us.
FDA’s pilot cohort scored 2.40–4.62 on the five-point scale. The patterns inside the data.