Stripe is to Payments. ComplianceIQ == Pharma AI Readiness.
Universal AI Compliance Infrastructure
Stop letting compliance freeze your AI projects. Embed our developer-first API to achieve minimal technical debt and deploy in days, not months.
Trusted by top pharmaceutical innovators across global jurisdictions.
Manual compliance is hostile to speed, costing millions and exposing you to regulatory fines.
ComplianceIQ helps ensure validation and audit readiness in real-time. Innovation is accelerated; risk is minimized.
Integrate compliance at the code level, project management layer, or executive dashboard—we fit your workflow.
For ML Engineers & Data Scientists
from complianceiq import SDK
result = SDK.check_model(...)For Product Owners & Project Managers
For C-Suite & Audit Teams
Automated assessment against 156 regulatory standards including FDA 21 CFR Part 11, EU AI Act, GAMP 5, and ICH guidelines. Get comprehensive compliance scoring in days, not months.
Validate AI models for bias, fairness, and explainability. Ensure your models meet FDA requirements for transparency and can be validated for regulatory submission.
Continuous monitoring of AI models in production. Get instant alerts when compliance risks are detected, ensuring ongoing regulatory adherence.
Get a comprehensive FIVES Score (0-5) for each AI project. Identify high-risk projects early and fast-track FDA-ready projects to production.
Validate against FDA, EMA, PMDA, Health Canada, and 15+ other jurisdictions. Ensure global compliance from day one.
Generate complete audit trails and regulatory documentation. Every assessment produces submission-ready reports for FDA inspections.
Validate AI models before production deployment. Get instant feedback on compliance gaps and fix issues early in the development cycle.
Assess entire AI project portfolios in days, not months. Prioritize high-risk projects and ensure regulatory readiness across all initiatives.
Ensure AI initiatives meet legal and regulatory requirements. Get comprehensive risk analysis and compliance documentation for board reporting.
Integrate compliance validation into CI/CD pipelines. Automate compliance checks as part of your software development lifecycle.
By identifying high-risk AI projects early, this enterprise pharma company avoided millions in wasted R&D investment. ComplianceIQ assessments revealed compliance gaps in multiple projects that would have failed FDA review.
ComplianceIQ connects seamlessly with AskRexi, ClinoxisCore, DataGovernanceIQ, RegIQ, and other tfives platforms. When ComplianceIQ detects AI risk, AskRexi automatically checks regulations, and ClinoxisCore provides compliance marketplace APIs.
ComplianceIQ is an AI/ML Readiness & Governance Platform that provides 48-hour AI compliance assessments for pharmaceutical companies. It validates ML models against 156 regulatory standards including FDA 21 CFR Part 11, EU AI Act, GAMP 5, and ICH guidelines.
ComplianceIQ provides comprehensive AI compliance assessments typically within 48 hours, compared to months of manual validation. This includes assessment against 156 regulatory standards, bias detection, explainability validation, and audit-ready documentation.
ComplianceIQ validates against comprehensive regulatory standards including FDA 21 CFR Part 11, EU AI Act, GAMP 5, ICH guidelines, and multiple jurisdictions worldwide including FDA, EMA, PMDA, Health Canada, and more.
ComplianceIQ offers three deployment options: API for developers (Python & JavaScript SDKs), Widget for project managers (low-code drag-and-drop), and SaaS for executives (single pane of glass dashboard). It integrates with CI/CD pipelines, Veeva, MasterControl, Medidata, and other pharmaceutical systems.
Minimal technical debt means ComplianceIQ is designed to eliminate legacy code, avoid vendor lock-in, and reduce integration complexity. Our API-first architecture ensures clean integration that doesn't create technical debt for your organization.
ComplianceIQ is designed for Data Scientists & ML Engineers (pre-production validation), Compliance Directors (portfolio-wide assessment), General Counsel (legal risk assessment), and IT/GxP Systems Leads (CI/CD integration). It serves pharmaceutical companies from emerging biotech to top 10 global pharma.
Join the infrastructure for the AI Economy.
Start your journey to compliance-focused approach and 12-month faster deployment.
No credit card required. See your risk profile in minutes.