Regunalys converts agency inspection information (e.g., FDA, EMA, Health Canada, others) into Inspection Intelligence- so Quality Auditors and Quality Leaders can plan for high-risks, strengthen compliance, and benchmark globally for Pharmaceuticals.
Regunalys delivers agency Inspection Intelligence to pharmaceutical manufacturers and their Quality organizations. We build searchable inspection records and analytics from multiple agencies globally like FDA, EMA, Health Canada, & others and convert them into decision-ready insight.
One pane of glass for FDA, EMA, and Health Canada inspection outcomes - for cross-region analysis.
Observations linked to GMP Regulatory Requirements.
Spot trends by CFR section, site type, product class, timeframe, and geography. Compare against peers.
Instant access to Form 483s, EIRs, Warning Letters, and citations with advanced filters and source links.
Faster preparation, stronger analysis, and a clear view of what regulators are finding - so you can proactively remediate and prevent observations.
Observations related to contamination control and aseptic practices frequently appear across parenteral operations.
Trends often cluster around ALCOA+ gaps—access control, audit trails, and contemporaneous recording.
Benchmark with other sites by product type and observation metrics to target audits where they matter most.
Insights above are examples for demonstration; connect with us for current analytics and agency-specific breakdowns.
Analytics are anchored to original agency documents (Form 483s, EIRs, Warning Letters), inspection citations and other relevant materials for traceability.
Observation mapping to GMP supports rapid impact assessment.
Crafted with a Audit and Quality Leaders workflow in mind: fast, precise, and defensible.
Have a question or want to book time at the conference? Reach out to admim@regunalys.com
