AI-Powered
Regulatory Gap Analysis
Upload your quality documents and get comprehensive compliance analysis in minutes. Our COG platform identifies gaps across multiple regulatory frameworks with severity ratings and actionable remediation guidance.
Regulatory Frameworks
Choose from our growing library of regulatory frameworks. Each analysis is tailored to the specific requirements and expectations of your industry.
ISO 13485 Analysis
Medical Device QMS Compliance
Comprehensive gap analysis against ISO 13485:2016 and 21 CFR Part 820 requirements. Evaluate your quality management system for medical device regulatory compliance.
DSCSA Analysis
Drug Supply Chain Security
Verify compliance with Drug Supply Chain Security Act requirements. Assess your transaction data, verification, and serialization procedures.
CGT Analysis
Cell & Gene Therapy Compliance
Evaluate your quality systems against cell and gene therapy regulatory requirements including tissue regulations and biologics standards.
Aseptic Processing Analysis
Sterile Manufacturing Compliance
Assess your aseptic processing and sterile manufacturing practices against FDA guidance and EU GMP Annex 1 requirements.
PDMP Analysis
Fractionated Plasma Products
Comprehensive analysis of plasma derivative manufacturing operations against FDA regulations for blood and blood products.
503(b) Compounding Analysis
Outsourcing Facility Compliance
Evaluate your 503(b) outsourcing facility against FDA cGMP requirements and state board of pharmacy regulations.
How It Works
Get from document upload to actionable insights in five simple steps.
Upload Documents
Upload your SOPs, policies, work instructions, and other quality documents to the COG platform.
Select Framework
Choose the regulatory framework(s) you want to assess against—ISO 13485, DSCSA, CGT, and more.
AI Analysis
Our AI analyzes your documents against the selected regulatory requirements, identifying gaps and compliance issues.
Review Findings
Review severity-rated findings with specific gap descriptions, current state assessment, and remediation recommendations.
Generate Reports
Download professional PDF reports with executive summaries, detailed findings, and coverage matrices.
Platform Features
Everything you need to assess, understand, and improve your regulatory compliance posture.
Automated Document Analysis
Upload SOPs, policies, and procedures. Our AI analyzes your documents against regulatory requirements in minutes.
Severity-Rated Findings
Each gap is categorized by severity—Critical, Major, Minor, or Observation—helping you prioritize remediation efforts.
Remediation Guidance
Receive specific, actionable recommendations for addressing each identified gap with regulatory references.
Coverage Matrix
Visualize which regulatory requirements are addressed by your documents and where gaps exist.
Professional Reports
Generate comprehensive PDF reports suitable for management review, audit preparation, or regulatory submissions.
Rapid Turnaround
Get results in minutes, not days. Our AI-powered analysis dramatically reduces assessment time.
Need Help With Remediation?
Our gap analysis is just the beginning. Our consulting team can help you:
- Prioritize findings based on risk and regulatory impact
- Develop remediation plans with realistic timelines
- Author compliant SOPs and documentation
- Implement quality system improvements
- Prepare for regulatory inspections
Typical Engagement
Gap Analysis
AI-powered assessment identifies compliance gaps
Findings Review
Expert review and prioritization of findings
Remediation Planning
Develop actionable remediation roadmap
Implementation Support
Hands-on assistance closing identified gaps
Simple, Transparent Pricing
Pay per document analyzed. No subscriptions, no hidden fees.
Ready to assess your compliance posture?
Upload your first document and see the power of AI-driven gap analysis. No commitment required.