Regulatory & Quality Suite
The Only AI-Powered Platform That Validates Itself for FDA Submission. Automatically generates IQ, OQ, PQ validation documentation as part of every CAPA workflow—ensuring your submissions are FDA-ready from day one.
RegIQ is the first pharmaceutical regulatory and quality management platform that automatically generates IQ, OQ, PQ validation documentation as part of every CAPA workflow—ensuring your submissions are FDA-ready from day one.
Traditional CAPA and quality management systems require manual validation tracking, static workflows, and reactive management. RegIQ transforms this with automatic validation, self-learning AI, and predictive capabilities.
Every CAPA automatically detects and links to required IQ, OQ, PQ validations—no manual tracking, no missed validations.
Absorbs ANY data source—no matter how messy, incomplete, or poorly formatted—and transforms it into FDA-ready, compliant information.
Add new data sources, systems, or processes without stopping operations—all while maintaining full FDA 21 CFR Part 11 compliance.
Self-learning knowledge engine identifies systemic issues before they become CAPAs, reducing deviations by up to 40%.
AI transforms CAPA from "Corrective + Preventive" to "Automatic, Preventive, and Prescriptive" with complete lifecycle management and automatic validation linkage. Every CAPA automatically detects and links to required IQ, OQ, PQ validations.
ICH M2 & designed for FDA compliance with automatic XML backbone and submission structure generation, PDF/A conversion. All mandatory components: Structure Builder, XML Backbone Generator, PDF/A Converter, Heading Mapper, Document Assembler, FDA Forms Handler, Validation Engine, FDA ESG Integration, Submission Packager.
Automated eCTD generation with FDA ESG integration. Streamline Chemistry, Manufacturing, and Controls submissions with automatic validation and compliance checking.
Medical device regulation compliance with automatic detection. Track and manage MDR submissions with automatic gap detection and remediation recommendations.
Comprehensive quality management for deviations, process parameters, and quality control. Track and manage all quality events with automated workflows.
Self-learning ecosystem that improves over time. AI learns your patterns and identifies systemic issues before they become CAPAs, reducing deviations by up to 40%.
ML-based risk assessment and effectiveness forecasting. Identify high-risk areas before they become problems and predict CAPA effectiveness.
Intelligent gatekeeping ensures compliance at every step, from CAPA to eCTD submission. Automatic gap analysis and remediation recommendations for all regulatory submissions.
Connect LIMS, DMS, CDMS, QMS, ERP, MES via API or data upload—zero downtime
Upload ready-made CAPA Dossiers, eCTD submissions, or MDR documents—we automatically check for gaps and provide remediation recommendations
Use RegIQ to track CAPA, eCTD, or MDR with automatic gap detection and remediation
PREDICTIVE_STRATEGIST
Never miss a validation requirement again. Every CAPA automatically links to IQ, OQ, PQ—your submissions are typically complete.
STRATEGIC_VALIDATOR
AI-assisted root cause analysis with multiple RCA methodologies. Evidence upload and validation ensure comprehensive investigations.
EXECUTION_EXPERT
Automatic task assignment and tracking. Action plan execution with effectiveness monitoring.
INTELLIGENT_GATEKEEPER
eCTD submissions generated automatically with FDA ESG integration. Upload ready-made submissions and we'll automatically check for gaps.
AI_GUIDED_OPERATOR
Proactive AI alerts and mobile-optimized tasks. Auto-CAPA generation from deviations.
SYSTEM_ADMIN
Add new data sources without downtime. Data Sponge Architecture absorbs ANY system—LIMS, DMS, CDMS, QMS—regardless of format.
Reduce CAPA cycle time by 30%, improve first-pass FDA approval rate, and eliminate compliance risk through predictive analytics. Transform quality management from a cost center into a competitive advantage.
Leading pharmaceutical companies using RegIQ have achieved high FDA submission success rates, up to 1% reduction in deviations, and minimal downtime during system integration.
RegIQ connects seamlessly with AskRexi, ClinoxisCore, ComplianceIQ, DataGovernanceIQ, and all tfives platforms. When RegIQ identifies deviations, AskRexi checks if it's a reportable event. When ClinoxisCore flags data integrity issues, RegIQ generates investigations. The Data Sponge Architecture ensures seamless integration with LIMS, DMS, CDMS, QMS, ERP, and MES systems.
Join leading pharmaceutical companies using the only platform that validates itself for FDA submission. No credit card required.