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AI-Powered Compliance Platform

Regulatory intelligence,
delivered in minutes

Upload SOPs, protocols, and technical files. Get instant gap analysis against FDA, ICH, EU, and ISO frameworks with specific citations. Evaluate TPS/COTS fit-for-use. Generate audit-ready reports.

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Compliance Dashboard
LIVE
Docs Analyzed
1,247
Compliance
94%
Gaps Found
12
Hours Saved
480
Core Capabilities

Built for the regulatory lifecycle

From gap assessments to audit prep, our platform covers the full spectrum of compliance needs across pharma, biotech, and medical devices.

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AI Compliance Analysis

Upload any document and get instant compliance assessment with specific regulatory citations. Our AI cross-references your content against the full text of applicable standards.

21 CFR Part 11ICH E6 (R3)EU Annex 11ISO 13485EU MDR
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TPS/COTS Fit-for-Use Assessment

Evaluate third-party and commercial off-the-shelf software using GAMP 5 2nd Edition categories and FDA's CSA risk-based framework. Determine validation scope based on intended use and risk.

GAMP 5 Cat 3/4/5FDA CSAIEC 62304Vendor Assessment
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Gap Assessment & Remediation

Automated gap identification across regulatory frameworks with prioritized remediation plans, risk ratings, and executive summaries ready for management review.

Risk-BasedRemediation PlansExecutive ReportsCAPA Tracking
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Regulatory Intelligence

Automated monitoring of FDA guidance, ICH updates, EU MDR changes, and ISO revisions. Get alerts when new requirements impact your compliance posture.

FDA AlertsICH UpdatesEU MDRISO Changes
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SaMD & Clinical Trial Support

Classification guidance per IMDRF framework, IEC 62304 lifecycle documentation, clinical evaluation support, and IEC 62366-1 usability engineering file generation.

SaMD ClassificationIEC 62304IEC 62366-1ISO 14155
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Data Integrity & Security

ALCOA+ assessment tools, audit trail reviews, 21 CFR Part 11 electronic records/signatures evaluation. 256-bit encryption with GDPR-ready infrastructure.

ALCOA+Audit TrailsE-SignaturesGDPR Ready
New Capability

TPS/COTS Fit-for-Use Assessment Engine

Evaluate any third-party or commercial off-the-shelf software against your intended use, GxP impact, and patient safety risk. Our engine applies GAMP 5 2nd Edition categorization and the FDA's Computer Software Assurance framework to determine appropriate validation scope.

01

Software Characterization

GAMP 5 category assignment (Cat 3 infrastructure, Cat 4 configured, Cat 5 custom). Intended use documentation.

02

Risk Assessment

GxP impact analysis, patient safety evaluation, data integrity risk scoring. Determines validation rigor per CSA principles.

03

Vendor Evaluation

Supplier quality assessment, development lifecycle review, support/maintenance capability scoring.

04

FFU Determination & Report

Final fit-for-use determination with validation strategy, testing scope, and ongoing monitoring requirements.

Assessment Matrix

Sample Output
SoftwareGAMP CatGxP RiskFFU Status
Veeva Vault QMS Cat 4 Medium Approved
Jira (GxP Config) Cat 4 Low Approved
Custom LIMS Module Cat 5 High Conditional
DocuSign eSign Cat 3 Low Approved
MasterControl QMS Cat 4 Medium Approved
In-House SaMD Cat 5 High Requires Full CSV
Interactive Demo

See RegulatoryIQ in action

Try our AI compliance assistant, explore document analysis, and review sample compliance reports.

RegulatoryIQ Assistant Demo Mode
RQ
Welcome. I can answer specific questions about FDA, ICH, EU, and ISO regulatory requirements with citations. Try a topic below or type your own question.
21 CFR Part 11 EU Annex 11 ALCOA+ ICH E6 (R3) GAMP 5 COTS IEC 62304

Document Analysis Portal

Upload and analyze compliance documents

Recent Analyses

Clinical_Protocol_v2.1.pdf
ICH E6 (R3) Analysis · 2 hours ago
Complete
Data_Management_Plan.pdf
21 CFR Part 11 Analysis · Processing
45%
SOP-DC-001_Doc_Control.docx
ISO 13485 Analysis · 1 day ago
Complete
COTS_Eval_Veeva.xlsx
GAMP 5 FFU Assessment · 3 days ago
Complete

Analysis Metrics

24
This Week
92%
Avg Score
6
FFU Assessed
148h
Time Saved

Compliance Report

Clinical_Protocol_v2.1.pdf · ICH E6 (R3)

92%

Overall Compliance Score

Based on ICH E6 (R3) Requirements

Electronic Signature Implementation

Section 5.5.3 · Electronic Systems
Low Risk

E-signature implementation meets requirements. Validation documentation present, audit trails configured, user authentication enforced per 21 CFR 11.100.

Data Integrity Controls

Section 4.9 · Records and Reports
Medium Risk

Backup procedures should be strengthened. Recommend implementing automated data verification checks to replace current manual processes, per ALCOA+ attributable and contemporaneous principles.

Audit Trail Review Frequency

Section 6.2.1 · Monitoring
High Risk

No documented periodic audit trail review process. EU Annex 11, Section 9 requires routine review. Recommend establishing SOP with defined review frequency and responsible personnel.

Template Packages

Ready-to-use compliance templates

Professional templates developed by regulatory experts. Download instantly and customize for your organization.

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21 CFR Part 11 Complete Package

Everything for Part 11 compliance
$299
One-time purchase
  • Electronic Records SOP Template
  • Electronic Signature SOP Template
  • System Validation Protocol
  • Audit Trail Review Checklist
  • User Access Control Matrix
  • Training Records Template
  • Risk Assessment Template
Instant download · Word & PDF
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GxP SOP Bundle

Essential SOPs for GxP compliance
$399
One-time purchase
  • Document Control SOP
  • Change Control SOP
  • Training Management SOP
  • CAPA Management SOP
  • Internal Audit SOP
  • Deviation Management SOP
  • Vendor Management SOP
Instant download · Fully customizable

Individual Template Packs

CSV Package

$199

URS, IQ, OQ, PQ protocols, traceability matrix, validation summary report

Clinical Trial Pack

$249

Protocol template, ICF, monitoring plan, SAE reporting, TMF index

EU MDR Package

$349

Technical documentation, clinical evaluation report, GSPR checklist, UDI procedures

ISO 13485 Kit

$299

Quality manual, management review, design control procedures, process validation

Data Integrity Pack

$179

ALCOA+ tools, data integrity SOPs, audit checklists, remediation templates

Audit Prep Bundle

$229

FDA inspection readiness, mock audit templates, 483 response templates

TPS/COTS FFU Toolkit

$279

Fit-for-use assessment forms, vendor questionnaire, GAMP 5 categorization, risk matrix

SaMD/IEC 62304 Pack

$349

Software lifecycle plan, architecture docs, unit/integration test protocols, risk management file

Complete Template Library

All 11 packages at 40% off

$2,930 $1,699
All 11 template packages 120+ ready-to-use templates Lifetime updates Priority support
Subscription Plans

AI-powered compliance analysis

Choose the plan that fits your needs. All plans include a 7-day free trial.

Starter
Perfect for small teams
$149/mo
  • 50 document analyses/month
  • 100 AI compliance queries
  • FDA & ICH frameworks
  • 48-hour turnaround
  • Email support
Enterprise
Custom solutions at scale
Custom
  • Everything in Professional
  • Unlimited users
  • Advanced API integration
  • Same-day turnaround
  • Dedicated success manager
  • Custom AI model training
  • On-premise deployment option
Platform Features

Everything you need for compliance

Built by regulatory professionals, powered by AI

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AI-Powered Analysis

Trained on thousands of regulatory documents. Provides compliance assessments with specific section-level citations you can verify.

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Real-Time Dashboards

Track compliance metrics, document status, and regulatory changes in customizable, exportable dashboards.

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Global Framework Coverage

FDA, EMA, MHRA, TGA, Health Canada, ANVISA, PMDA, and 40+ additional regulatory frameworks worldwide.

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Regulatory Intelligence

Automated monitoring of guidance updates, standard revisions, and enforcement trends that impact your compliance posture.

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Enterprise Security

256-bit AES encryption, GDPR-ready infrastructure, regular penetration testing, and role-based access controls.

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API & QMS Integration

Connect with Veeva, MasterControl, Qualio, TrackWise, and other QMS platforms through our documented REST API.

About Us

Built by regulatory professionals, for regulatory professionals

RegulatoryIQ was founded on a simple premise: compliance analysis shouldn't take weeks. Our team combines decades of regulatory affairs experience with cutting-edge AI to deliver answers in minutes.

Our Mission

We believe every life sciences company, from early-stage startups to global enterprises, deserves access to expert-level regulatory intelligence. Our platform democratizes compliance knowledge that was previously locked behind expensive consulting engagements and siloed institutional expertise.

50+
Regulatory Frameworks
10K+
Documents Analyzed
200+
Companies Served
98%
Accuracy Rate

Our Approach

Unlike generic AI tools, RegulatoryIQ is purpose-built for the regulatory landscape. Our models are trained exclusively on authoritative regulatory texts, guidance documents, and enforcement data. Every response includes verifiable citations so you can trust and trace the analysis back to its source.

We follow a risk-based approach aligned with modern frameworks like the FDA's Computer Software Assurance guidance and GAMP 5 2nd Edition. Our TPS/COTS Fit-for-Use assessment engine reflects current industry best practices for evaluating software in GxP environments.

Leadership

Our team brings experience from FDA, notified bodies, CROs, and top-tier life sciences companies. We hold certifications including RAC, CQE, CMQ/OE, CPHQ, LSSBB, and Lead Auditor qualifications. We don't just build compliance software; we live regulatory every day.

Resources

Guides, whitepapers, and regulatory references

Practical resources to help you navigate compliance challenges across FDA, ICH, EU, and ISO frameworks.

Guide

21 CFR Part 11 Compliance Roadmap

Step-by-step guide to achieving and maintaining compliance with FDA's electronic records and signatures requirements.

Whitepaper

CSA vs. CSV: Implementing Risk-Based Approaches

How to transition from traditional computer system validation to the FDA's Computer Software Assurance framework.

Checklist

EU Annex 11 Gap Assessment Checklist

Comprehensive checklist covering all operational and IT requirements of Annex 11 for computerized systems.

Guide

GAMP 5 2nd Edition: What Changed

Summary of key updates in GAMP 5 Second Edition and practical implications for your validation strategy.

Whitepaper

TPS/COTS Fit-for-Use Assessment Framework

A practical methodology for evaluating third-party and COTS software in GxP regulated environments.

Template

Data Integrity Self-Assessment Tool

Evaluate your organization's data integrity posture against ALCOA+ principles and current regulatory expectations.

Guide

SaMD Classification per IMDRF

Navigating the IMDRF risk categorization framework for Software as a Medical Device, including IEC 62304 implications.

Checklist

FDA Inspection Readiness Playbook

Pre-inspection preparation guide covering common 483 observations, back room logistics, and response strategies.

Additional resources are available to subscribers. Start your free trial to access the full library.

Help Center

Frequently asked questions

Find answers to common questions about RegulatoryIQ, our platform, and compliance services.

What regulatory frameworks does RegulatoryIQ cover?
We cover 50+ frameworks including FDA 21 CFR Part 11, ICH E6 (R3), EU Annex 11, EU MDR 2017/745, ISO 13485, ISO 14971, IEC 62304, IEC 62366-1, GAMP 5 2nd Edition, FDA CSA guidance, ALCOA+ data integrity, and many more. Our regulatory intelligence engine continuously monitors for updates.
How does the TPS/COTS Fit-for-Use assessment work?
You provide details about the software (vendor, intended use, configuration level, GxP impact). Our engine applies GAMP 5 2nd Edition categorization (Cat 3/4/5), assesses GxP risk and patient safety impact, evaluates vendor quality systems, and generates a fit-for-use determination with recommended validation scope aligned to FDA's CSA principles.
How accurate are the AI compliance assessments?
Our AI achieves 98% accuracy on standard compliance queries, validated against expert regulatory assessments. Every response includes specific citations (section, paragraph, clause) so you can independently verify. We recommend using our outputs as a starting point for your compliance activities, not as a substitute for qualified regulatory judgment.
Where are my documents stored?
Documents are encrypted at rest (AES-256) and in transit (TLS 1.3), stored in SOC 2-audited cloud infrastructure. Documents are processed for analysis and can be deleted at any time. We never share your documents with third parties or use them to train our models.
Can I integrate RegulatoryIQ with my existing QMS?
Yes. Our REST API supports integration with Veeva Vault, MasterControl, Qualio, TrackWise, and other QMS platforms. Professional and Enterprise plans include API access. We also support webhook notifications for completed analyses.
What file types are supported for document analysis?
We accept PDF, DOCX, XLSX, PPTX, and plain text files. Maximum file size is 50MB per document on Professional plans, with higher limits for Enterprise. Batch upload is available for analyzing multiple documents against the same framework.
How do template packages work?
Templates are one-time purchases delivered as instant downloads in Word and/or Excel format. They're fully customizable for your organization. Templates are developed by certified regulatory professionals and reflect current regulatory expectations. Lifetime updates are included with the Complete Library bundle.
Is there a free trial?
Yes. All subscription plans include a 7-day free trial with full feature access. No credit card required to start. You can cancel anytime during the trial with no charges.

Still have questions?