Find compliance gaps
before your auditor does
AI-powered gap analysis in under 60 seconds. Upload your SOP, select a regulatory framework, and get a risk-rated report with clause-level findings and specific remediation actions. Backed by 14+ years of hands-on audit experience across FDA, ICH, EU MDR, and 25+ frameworks.
AI Gap Analysis
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How It Works
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Upload your document
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Select a regulatory framework
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Get your gap analysis report
What You Get
Template packages for every compliance need
Gap Assessment Toolkit
Six major compliance frameworks in one integrated toolkit. FDA Part 11, EU Annex 11, ICH E6(R3), ALCOA+, CSV/CSA, and QMSR/ISO 13485.
CSV/CSA Package
FDA Computer Software Assurance framework transition from traditional CSV. Risk-based approach with vendor assessment and testing protocols.
21 CFR Part 11 Complete
Full Part 11 lifecycle from compliance planning through periodic review. Includes the 11.100(c) certification letter most packs miss.
TPS/COTS Fit-for-Use Toolkit
Vendor qualification, risk classification, and ongoing monitoring for third-party and COTS software. Four industry modules included.
Data Integrity Pack
ALCOA+ compliance and data governance across 5 international frameworks. Risk assessment with 45 pre-populated scenarios and automatic RPN calculation.
EU AI Act Assessment Pack
The only life sciences-specific EU AI Act compliance toolkit. MDR/IVDR dual-compliance, pharma manufacturing AI coverage, NIST AI RMF cross-mapping, and dual-timeline planning.
All templates: editable .docx & .xlsx, no DRM, unlimited sites. Digital delivery within 1 business hour.
30-day money-back guarantee on every purchase.
Six pillars of compliance intelligence
Regulatory Document Review
Expert analysis of your SOPs, validation protocols, and quality system documentation against applicable regulatory frameworks. Identifies non-conformities, maps requirements to existing evidence, and delivers risk-prioritized findings with specific clause references.
21 CFR Part 11 · ISO 13485 · EU MDRThird-Party Software (TPS) / COTS Fit-for-Use Assessment
GAMP 5 2nd Edition categorization with FDA CSA (Feb 2026) risk-based evaluation framework. Vendor assessment, intended use documentation, and process risk determination for commercial off-the-shelf (COTS) and configured products.
GAMP 5 · FDA CSA · Vendor QualificationGap Assessment & Remediation
Clause-level gap identification with risk-rated findings and prioritized remediation plans. Each gap maps to specific regulatory clauses with recommended corrective actions, responsible parties, and target timelines.
Risk-rated · Clause-level · ActionableQMSR Transition Support
Navigate the shift from 21 CFR Part 820 to ISO 13485:2016 under the QMSR, effective February 2, 2026. Gap analysis of your current QMS against ISO 13485 requirements, documentation crosswalk, and transition planning with defined milestones.
QMSR · ISO 13485:2016 · 21 CFR Part 820SaMD & Clinical Trial Support
IMDRF classification, IEC 62304 software lifecycle, IEC 62366-1 usability engineering, and ISO 14155 clinical investigation planning. End-to-end support from software classification through clinical evidence generation.
IMDRF · IEC 62304 · IEC 62366-1 · ISO 14155Data Integrity & Security
ALCOA+ assessment methodology, audit trail reviews, 21 CFR Part 11 electronic records/signatures compliance. Covers the 2003 Scope and Application guidance and 2024 expanded interpretation for cloud and digital health technologies.
ALCOA+ · 21 CFR Part 11 · Audit TrailsRegulatory Advisory Services
AI Analysis Expert Review
Run our $79 AI gap analysis first, then bring the findings to an expert review. Get validation of AI-identified gaps, additional context the tool cannot capture, and a prioritized implementation roadmap with realistic timelines.
Gap Assessment Review
Have your gap assessment findings reviewed by an experienced auditor. Get a prioritized remediation roadmap with risk-rated action items and realistic timelines.
QMS & Compliance Consulting
From QMSR transition planning to SaMD classification, get hands-on guidance from someone who has done it.
Mock Audit & Inspection Readiness
Know what an auditor will find before they find it. Mock audits modeled on real FDA, Notified Body, and Sponsor/CRO audit approaches.
Typical response within 1 business hour. Initial 15-minute scoping calls are complimentary.
Built by a regulatory professional, not a tech startup
Quality and regulatory affairs leader with 14+ years guiding medical device, pharmaceutical, Software as a Medical Device (SaMD), and clinical trial programs through global regulatory requirements. Hands-on experience leading regulatory and quality operations across FDA, EU MDR, MHRA, TGA, Health Canada, PMDA, ISO 13485, and ICH GCP frameworks.
- No critical findings across 60+ completed regulatory and Sponsor/CRO audits
- Led quality operations through a $13M digital therapeutics merger, harmonizing QMS processes and maintaining multi-framework compliance
- Built SaMD validation frameworks supporting FDA pre-submissions, 510(k), and De Novo applications
- Compressed CAPA resolution timelines by 59% and reduced audit findings by 60% through process optimization
- Consulting engagements spanning medical device compliance, usability engineering (IEC 62366-1), data integrity risk assessments, QMSR/ISO 13485 mock audits, and QMS buildout for healthcare technology platforms
- Combines deep regulatory expertise with AI and machine learning capabilities, including development of this platform
"Every template and assessment is built from hands-on audit experience, not generated by AI and left unreviewed. When you buy from RegulatoryIQ, you're getting the same frameworks I use in real consulting engagements."