ComplianceIQ

Stripe is to Payments. ComplianceIQ == Pharma AI Readiness.

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.

Know more →

THE BEFORE

Manual compliance is hostile to speed, costing millions

and exposing you to regulatory fines.

Months to Production

Unmanaged Technical Debt

70% Project Failure Rate

THE AFTER

ComplianceIQ helps ensure validation and

audit readiness in real-time.

Innovation is accelerated; risk is minimized.

From Months to Days

From Months to Days

Up to 50% Improved Productivity

The Deployment Flexibility You Need

Integrate compliance at the code level, project management layer, or executive dashboard—we fit your workflow.

Integrate compliance at the code level, project management layer,

or executive dashboard—we fit your workflow.

API: Developer-First

For ML Engineers & Data Scientists

  • Embed checks into CI/CD pipeline
    or notebook

  • minimizes Technical Debt

from complianceiq import SDK

result = SDK.check_model(...)

Widget: Project Management

For Product Owners & Project Managers

  • Low-code, drag-and-drop
    workflow component

  • Track status and utilize
    Human-in-the-Loop system

Drag & Drop Interface

SaaS: Executive Overview

For C-Suite & Audit Teams

  • Single pane of glass
    for all AI initiatives

  • Track AI Digital Twin and
    ensure Audit Readiness

Executive Dashboard

Key Capabilities

48-Hour AI Readiness Assessment

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.

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.

Bias Detection & Explainability

Validate AI models for bias, fairness, and explainability. Ensure

your models meet FDA requirements for transparency and can be

validated for regulatory submission.

Validate AI models for bias, fairness, and explainability.

Ensure your models meet FDA requirements for transparency

and can be validated for regulatory submission.

Real-Time Compliance Monitoring

Continuous monitoring of AI models in production. Get instant

alerts when compliance risks are detected, ensuring ongoing

regulatory adherence.

Compliance Scoring & Risk Analysis

Get a comprehensive FIVES Score (0-5) for each AI project.

Identify high-risk projects early and fast-track FDA-ready

projects to production.

19-Jurisdiction Coverage

Validate against FDA, EMA, PMDA, Health Canada, and 15+ other

jurisdictions. Ensure global compliance from day one.

Validate against FDA, EMA, PMDA, Health Canada,

and 15+ other jurisdictions. Ensure global compliance from

day one.

Audit-Ready Documentation

Generate complete audit trails and regulatory documentation.

Every assessment produces submission-ready reports for FDA

inspections.

Who Uses ComplianceIQ

Data Scientists & ML Engineers

Validate AI models before production deployment.

Get instant feedback on compliance gaps and fix issues

early in the development cycle.

✓ Pre-production compliance validation


✓ Bias and fairness testing


✓ Model explainability validation

Compliance Directors

Assess entire AI project portfolios in days, not months.

Prioritize high-risk projects and ensure regulatory readiness

across all initiatives.

✓ Portfolio-wide compliance assessment


✓ Risk-based project prioritization


✓ Audit-ready compliance reports

General Counsel

Ensure AI initiatives meet legal and regulatory requirements.

Get comprehensive risk analysis and compliance documentation

for board reporting.

Ensure AI initiatives meet legal and regulatory

requirements. Get comprehensive risk analysis and

compliance documentation for board reporting.

✓ Legal risk assessment


✓ EU AI Act readiness


✓ Regulatory compliance documentation

IT/GxP Systems Leads

Integrate compliance validation into CI/CD pipelines.

Automate compliance checks as part of your software

development lifecycle.

✓ API-based compliance validation


✓ CI/CD pipeline integration


✓ Automated compliance testing

Proven Results

Enterprise Pharma Company Achieves Significant Savings

Enterprise Pharma Company

Achieves Significant Savings

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.

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.

Millions

Saved

6 Months

Faster to Market

High

FDA Approval Rate

Industry-
Leading

First-Time

Approval Rate

48 hours

vs. 6 Months Manual

156

Regulatory Standards

Integrates with Your Workflow

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.

CommercialCore offers 8 integrated use cases on one platform. Use any combination.

Switch them on or off as your needs change. One platform.

One data source. One compliance engine. Your choice of use cases.

Frequently Asked Questions

What is ComplianceIQ?

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 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.

How long does a ComplianceIQ assessment take?

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 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.

What regulatory standards does ComplianceIQ validate against?

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 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.

How does ComplianceIQ integrate with existing systems?

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.

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.

What is minimal technical debt?

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.

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.

Who should use ComplianceIQ?

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.

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.