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Compliance & Governance Advisory Programs

We build governance frameworks and compliance programs aligned with your regulatory obligations. From risk mapping and control environment design to managed compliance and supply chain due diligence — serving commercial organizations in EU and US across regulated industries.

Small

Companies assessing compliance gaps before audit

$6,500 /total

Compliance & Regulatory Risk Assessment: Risk-ranked findings, Regulatory gaps, Priority action plan, Applicable regulations, Control gaps, Independent assessment, Operational scoping, Senior advisor, Actionable deliverable.
Governance Framework & Control Architecture: Not included
EU CS3D & Supply Chain Due Diligence Framework: Not included.
Regulatory Landscape Analysis & Monitoring: Applicable regulations, Industry mapping, Geography scoping, EU and US coverage, Obligation summary, Regulatory applicability, Standards identification, Enforcement risks, Jurisdiction analysis
Fractional Compliance Leadership & Advisory: Not included.

Medium

Mid-market firms building compliance structure

$35,000 /total

Compliance & Regulatory Risk Assessment: Comprehensive assessment, Multi-jurisdictional, Control gap analysis, Risk register, Obligation mapping, Exposure quantification, Framework foundation, Stakeholder profiling, EU and US Coverage
Governance Framework & Control Architecture: Governance framework, Control architecture, Regulatory mapping, Policy development, SOP documentation, Control register, Accountability mapping, Board-ready structure, Operational integration.
EU CS3D & Supply Chain Due Diligence Framework: Value chain mapping, Supplier mapping, CS3D obligations, Supplier code of conduct, Grievance mechanisms, Due diligence procedures, Human rights assessment, Reporting infrastructure
Regulatory Landscape Analysis & Monitoring: Multi-jurisdictional mapping, Obligation register, ISO and EU alignment, Comprehensive coverage, Enforcement landscape, Obligation prioritization, Regulatory calendar, Framework integration
Fractional Compliance Leadership & Advisory: Not included.

Large

Organizations needing compliance leadership

$120,000 /total

Compliance & Regulatory Risk Assessment: Quarterly reviews, Continuous monitoring, Regulation alerts, Live risk register, Change integration, Control effectiveness, Annual reassessment, Incident risk tracking, Real-time alerts, KPI Dashboard
Governance Framework & Control Architecture: Governance maintenance, Control updates, Policy revisions, Structural adjustments, Regulatory integration, Control effectiveness, Framework evolution, Annual review, Gap monitoring, Continuous align
EU CS3D & Supply Chain Due Diligence Framework: Supplier monitoring, CS3D maintenance, Annual due diligence cycle, Incident escalation, Regulatory tracking, Engagement program, Grievance oversight, Reporting management, New supplier compliance
Regulatory Landscape Analysis & Monitoring: Continuous monitoring, Monthly alerts, Enforcement tracking, New obligations, Regulatory calendar, Guidance review, Compliance intelligence, Annual landscape review, Jurisdiction expansion
Fractional Compliance Leadership & Advisory: Monthly advisory, Strategic guidance, Regulatory response, Board reporting, Incident response, Senior advisor access, Team development, Program ownership, Stakeholder communication, embedded advisory
12 month delivery

Features	Small $6,500 /total	Medium $35,000 /total	Large $120,000 /total
Compliance & Regulatory Risk Assessment	Risk-ranked findings, Regulatory gaps, Priority action plan, Applicable regulations, Control gaps, Independent assessment, Operational scoping, Senior advisor, Actionable deliverable.	Comprehensive assessment, Multi-jurisdictional, Control gap analysis, Risk register, Obligation mapping, Exposure quantification, Framework foundation, Stakeholder profiling, EU and US Coverage	Quarterly reviews, Continuous monitoring, Regulation alerts, Live risk register, Change integration, Control effectiveness, Annual reassessment, Incident risk tracking, Real-time alerts, KPI Dashboard
Governance Framework & Control Architecture	Not included	Governance framework, Control architecture, Regulatory mapping, Policy development, SOP documentation, Control register, Accountability mapping, Board-ready structure, Operational integration.	Governance maintenance, Control updates, Policy revisions, Structural adjustments, Regulatory integration, Control effectiveness, Framework evolution, Annual review, Gap monitoring, Continuous align
EU CS3D & Supply Chain Due Diligence Framework	Not included.	Value chain mapping, Supplier mapping, CS3D obligations, Supplier code of conduct, Grievance mechanisms, Due diligence procedures, Human rights assessment, Reporting infrastructure	Supplier monitoring, CS3D maintenance, Annual due diligence cycle, Incident escalation, Regulatory tracking, Engagement program, Grievance oversight, Reporting management, New supplier compliance
Regulatory Landscape Analysis & Monitoring	Applicable regulations, Industry mapping, Geography scoping, EU and US coverage, Obligation summary, Regulatory applicability, Standards identification, Enforcement risks, Jurisdiction analysis	Multi-jurisdictional mapping, Obligation register, ISO and EU alignment, Comprehensive coverage, Enforcement landscape, Obligation prioritization, Regulatory calendar, Framework integration	Continuous monitoring, Monthly alerts, Enforcement tracking, New obligations, Regulatory calendar, Guidance review, Compliance intelligence, Annual landscape review, Jurisdiction expansion
Fractional Compliance Leadership & Advisory	Not included.	Not included.	Monthly advisory, Strategic guidance, Regulatory response, Board reporting, Incident response, Senior advisor access, Team development, Program ownership, Stakeholder communication, embedded advisory

Small $6,500 /total
Compliance & Regulatory Risk Assessment	Risk-ranked findings, Regulatory gaps, Priority action plan, Applicable regulations, Control gaps, Independent assessment, Operational scoping, Senior advisor, Actionable deliverable.
Governance Framework & Control Architecture	Not included
EU CS3D & Supply Chain Due Diligence Framework	Not included.
Regulatory Landscape Analysis & Monitoring	Applicable regulations, Industry mapping, Geography scoping, EU and US coverage, Obligation summary, Regulatory applicability, Standards identification, Enforcement risks, Jurisdiction analysis
Fractional Compliance Leadership & Advisory	Not included.

Medium $35,000 /total
Compliance & Regulatory Risk Assessment	Comprehensive assessment, Multi-jurisdictional, Control gap analysis, Risk register, Obligation mapping, Exposure quantification, Framework foundation, Stakeholder profiling, EU and US Coverage
Governance Framework & Control Architecture	Governance framework, Control architecture, Regulatory mapping, Policy development, SOP documentation, Control register, Accountability mapping, Board-ready structure, Operational integration.
EU CS3D & Supply Chain Due Diligence Framework	Value chain mapping, Supplier mapping, CS3D obligations, Supplier code of conduct, Grievance mechanisms, Due diligence procedures, Human rights assessment, Reporting infrastructure
Regulatory Landscape Analysis & Monitoring	Multi-jurisdictional mapping, Obligation register, ISO and EU alignment, Comprehensive coverage, Enforcement landscape, Obligation prioritization, Regulatory calendar, Framework integration
Fractional Compliance Leadership & Advisory	Not included.

Large $120,000 /total
Compliance & Regulatory Risk Assessment	Quarterly reviews, Continuous monitoring, Regulation alerts, Live risk register, Change integration, Control effectiveness, Annual reassessment, Incident risk tracking, Real-time alerts, KPI Dashboard
Governance Framework & Control Architecture	Governance maintenance, Control updates, Policy revisions, Structural adjustments, Regulatory integration, Control effectiveness, Framework evolution, Annual review, Gap monitoring, Continuous align
EU CS3D & Supply Chain Due Diligence Framework	Supplier monitoring, CS3D maintenance, Annual due diligence cycle, Incident escalation, Regulatory tracking, Engagement program, Grievance oversight, Reporting management, New supplier compliance
Regulatory Landscape Analysis & Monitoring	Continuous monitoring, Monthly alerts, Enforcement tracking, New obligations, Regulatory calendar, Guidance review, Compliance intelligence, Annual landscape review, Jurisdiction expansion
Fractional Compliance Leadership & Advisory	Monthly advisory, Strategic guidance, Regulatory response, Board reporting, Incident response, Senior advisor access, Team development, Program ownership, Stakeholder communication, embedded advisory

ISO 9001:2026 QMS Implementation & Audit Readiness

We implement Quality Management Systems that survive audits and scale with your operations. From ISO 9001:2026 gap analysis and certification readiness to full QMS architecture and ongoing audit support — built for manufacturing, medical devices, and regulated industries across EU and US.

Small

ISO certified manufacturers needing 2026 readiness

$5,000 /total

ISO 9001:2026 Gap Analysis & Remediation Roadmap: Gap register, Clause mapping, Remediation roadmap, Certification timeline, Evidence gap, 2 weeks, ISO 9001:2026 DIS, Priority findings, Senior advisor, Actionable output
Audit Preparation & Certification Support: Pre-audit walkthrough, Evidence gaps, Audit readiness report, Mock examiner, Findings report, NCR risk flagging, Document check, Certification prep, 2 weeks, Senior advisor review.
QMS Documentation & SOP Development: Not included.
CAPA Loop Architecture & Management: Not included.
Internal Audit Program Design & Facilitation: Not included.

Medium

Companies seeking ISO 9001 certification

$25,000 /total

ISO 9001:2026 Gap Analysis & Remediation Roadmap: Full QMS gap, Operational conformance, Documentation gaps, Systemic review, Remediation project plan, Root cause, Process observation, Records sampling, Staff interview
Audit Preparation & Certification Support: Full mock audit, NCR remediation, Evidence organization, CAR development, First certificate support, Clause review, Auditor coaching, Staff preparation, Certification coordination, Post-audit debrief.
QMS Documentation & SOP Development: Quality manual, Procedures development, Work instructions, Forms and templates, Document control, Version management, SOP library, Audit-ready formatting, Regulatory alignment, Operational usability.
CAPA Loop Architecture & Management: system design, Trigger criteria, Root cause methodology, Effectiveness verification, Escalation framework, Workflow mapping, Preventive action, CAPA training, Closure standards, QMS integration.
Internal Audit Program Design & Facilitation: Annual audit schedule, ISO 9001:2026 checklists, Auditor competency, Reporting templates, Audit scope design, Process-based approach, Finding classification, Program documentation, Auditor guidance.

Large

Organization needing continuous compliance support

$96,000 /total

ISO 9001:2026 Gap Analysis & Remediation Roadmap: Quarterly gap reviews, Continuous monitoring, Remediation tracking, Surveillance readiness, Requirement updates, Control effectiveness, Annual reassessment, Regulatory integration
Audit Preparation & Certification Support: Surveillance support, Ongoing NCR management, CAR tracking, Certification liaison, Continuous readiness, Finding trends, Recertification planning, Evidence maintenance, Audit schedule management
QMS Documentation & SOP Development: Documentation management, Version control, SOP updates, Regulatory integration, New process docs, Review cycles, Archive management, Change-triggered revisions, Format standards, Accessibility maint.
CAPA Loop Architecture & Management: Open CAPA tracking, Root cause review, Effectiveness monitoring, Trend analysis, CAPA reporting, Systemic issue identification, Preventive program, Aging alerts, CAPA KPIs, Continuous improvement.
Internal Audit Program Design & Facilitation: Ongoing facilitation, Auditor coaching, Findings review, Program monitoring, Schedule management, Cross-functional audits, Trend analysis, Continuous improvement, Unannounced audit support.
12 month delivery

Features	Small $5,000 /total	Medium $25,000 /total	Large $96,000 /total
ISO 9001:2026 Gap Analysis & Remediation Roadmap	Gap register, Clause mapping, Remediation roadmap, Certification timeline, Evidence gap, 2 weeks, ISO 9001:2026 DIS, Priority findings, Senior advisor, Actionable output	Full QMS gap, Operational conformance, Documentation gaps, Systemic review, Remediation project plan, Root cause, Process observation, Records sampling, Staff interview	Quarterly gap reviews, Continuous monitoring, Remediation tracking, Surveillance readiness, Requirement updates, Control effectiveness, Annual reassessment, Regulatory integration
Audit Preparation & Certification Support	Pre-audit walkthrough, Evidence gaps, Audit readiness report, Mock examiner, Findings report, NCR risk flagging, Document check, Certification prep, 2 weeks, Senior advisor review.	Full mock audit, NCR remediation, Evidence organization, CAR development, First certificate support, Clause review, Auditor coaching, Staff preparation, Certification coordination, Post-audit debrief.	Surveillance support, Ongoing NCR management, CAR tracking, Certification liaison, Continuous readiness, Finding trends, Recertification planning, Evidence maintenance, Audit schedule management
QMS Documentation & SOP Development	Not included.	Quality manual, Procedures development, Work instructions, Forms and templates, Document control, Version management, SOP library, Audit-ready formatting, Regulatory alignment, Operational usability.	Documentation management, Version control, SOP updates, Regulatory integration, New process docs, Review cycles, Archive management, Change-triggered revisions, Format standards, Accessibility maint.
CAPA Loop Architecture & Management	Not included.	system design, Trigger criteria, Root cause methodology, Effectiveness verification, Escalation framework, Workflow mapping, Preventive action, CAPA training, Closure standards, QMS integration.	Open CAPA tracking, Root cause review, Effectiveness monitoring, Trend analysis, CAPA reporting, Systemic issue identification, Preventive program, Aging alerts, CAPA KPIs, Continuous improvement.
Internal Audit Program Design & Facilitation	Not included.	Annual audit schedule, ISO 9001:2026 checklists, Auditor competency, Reporting templates, Audit scope design, Process-based approach, Finding classification, Program documentation, Auditor guidance.	Ongoing facilitation, Auditor coaching, Findings review, Program monitoring, Schedule management, Cross-functional audits, Trend analysis, Continuous improvement, Unannounced audit support.

Small $5,000 /total
ISO 9001:2026 Gap Analysis & Remediation Roadmap	Gap register, Clause mapping, Remediation roadmap, Certification timeline, Evidence gap, 2 weeks, ISO 9001:2026 DIS, Priority findings, Senior advisor, Actionable output
Audit Preparation & Certification Support	Pre-audit walkthrough, Evidence gaps, Audit readiness report, Mock examiner, Findings report, NCR risk flagging, Document check, Certification prep, 2 weeks, Senior advisor review.
QMS Documentation & SOP Development	Not included.
CAPA Loop Architecture & Management	Not included.
Internal Audit Program Design & Facilitation	Not included.

Medium $25,000 /total
ISO 9001:2026 Gap Analysis & Remediation Roadmap	Full QMS gap, Operational conformance, Documentation gaps, Systemic review, Remediation project plan, Root cause, Process observation, Records sampling, Staff interview
Audit Preparation & Certification Support	Full mock audit, NCR remediation, Evidence organization, CAR development, First certificate support, Clause review, Auditor coaching, Staff preparation, Certification coordination, Post-audit debrief.
QMS Documentation & SOP Development	Quality manual, Procedures development, Work instructions, Forms and templates, Document control, Version management, SOP library, Audit-ready formatting, Regulatory alignment, Operational usability.
CAPA Loop Architecture & Management	system design, Trigger criteria, Root cause methodology, Effectiveness verification, Escalation framework, Workflow mapping, Preventive action, CAPA training, Closure standards, QMS integration.
Internal Audit Program Design & Facilitation	Annual audit schedule, ISO 9001:2026 checklists, Auditor competency, Reporting templates, Audit scope design, Process-based approach, Finding classification, Program documentation, Auditor guidance.

Large $96,000 /total
ISO 9001:2026 Gap Analysis & Remediation Roadmap	Quarterly gap reviews, Continuous monitoring, Remediation tracking, Surveillance readiness, Requirement updates, Control effectiveness, Annual reassessment, Regulatory integration
Audit Preparation & Certification Support	Surveillance support, Ongoing NCR management, CAR tracking, Certification liaison, Continuous readiness, Finding trends, Recertification planning, Evidence maintenance, Audit schedule management
QMS Documentation & SOP Development	Documentation management, Version control, SOP updates, Regulatory integration, New process docs, Review cycles, Archive management, Change-triggered revisions, Format standards, Accessibility maint.
CAPA Loop Architecture & Management	Open CAPA tracking, Root cause review, Effectiveness monitoring, Trend analysis, CAPA reporting, Systemic issue identification, Preventive program, Aging alerts, CAPA KPIs, Continuous improvement.
Internal Audit Program Design & Facilitation	Ongoing facilitation, Auditor coaching, Findings review, Program monitoring, Schedule management, Cross-functional audits, Trend analysis, Continuous improvement, Unannounced audit support.

AI Governance & EU AI Act Compliance Advisory

We apply quality management discipline to AI systems — ensuring model outputs, data pipelines, and algorithmic decisions are audit-ready under the EU AI Act. From deployer obligation mapping and high-risk AI system classification to governance framework design and ongoing algorithmic oversight programs.

Small

Companies deploying AI needing EU AI Act clarity

$8,000 /total

EU AI Act Risk Classification & Obligation Mapping: AI system inventory, Risk tier classification, High-risk identification, Deployer obligations, Compliance gaps, Priority roadmap, Annex III assessment, Senior advisor, Obligation map
High-Risk AI System Governance Design: Not included.
Human Oversight Framework & Accountability Design: Not included.
AI QMS Integration & Algorithmic Audit Readiness: Audit readiness review, Evidence gaps, Documentation weaknesses, Oversight gaps, Pre-scrutiny review, Readiness scoring, Quick wins, AI governance snapshot, Customer audit prep, senior advisor asses
EU AI Act Regulatory Monitoring & Compliance Updates: Not included.

Medium

Organization building AI governance infrastructure

$40,000 /total

EU AI Act Risk Classification & Obligation Mapping: Portfolio assessment, Full obligation mapping, Governance foundation, Risk architecture, Deployer requirements, Classification register, EU AI Act alignment, Prohibited practice screening
High-Risk AI System Governance Design: Human oversight design, Monitoring procedures, Incident reporting, Documentation requirements, Deployer architecture, Accountability mapping, Oversight role assignments, Intervtion criteria
Human Oversight Framework & Accountability Design: Oversight role design, Intervention criteria, Escalation procedures, Competency requirements, Accountability mapping, Decision review framework, Oversight documentation, Human-in-the-loop
AI QMS Integration & Algorithmic Audit Readiness: QMS integration, Model oversight connection, CAPA loop integration, Audit program alignment, Documentation control, Operational system design, Algorithmic audit program, Evidenence architecture
EU AI Act Regulatory Monitoring & Compliance Updates: Not included.

Large

Organizations needing continuous AI Act compliance

$144,000 /total

EU AI Act Risk Classification & Obligation Mapping: Continuous classification, New system review, Portfolio tracking, Regulatory integration, Ongoing obligation mapping, Register maintenance, Enforcement alert, Annual reassessment, new deployment check
High-Risk AI System Governance Design: Governance maintenance, Oversight reviews, Incident management, Role updates, Procedure updates, Intervention tracking, Documentation maintenance, Regulatory integration, Annual governance review
Human Oversight Framework & Accountability Design: Program management, Effectiveness monitoring, Role updates, Competency gap tracking, Intervention review, Escalation effectiveness, Accountability audits, Oversight KPIs, Quarterly reviews
AI QMS Integration & Algorithmic Audit Readiness: Ongoing readiness, Evidence management, QMS reviews, Inspection preparation, Customer audit support, Audit facilitation, Evidence updates, Trend analysis, Continuous monitoring, annual program review
EU AI Act Regulatory Monitoring & Compliance Updates: Monthly enforcement updates, Guidance tracking, Emerging obligations, Regulatory briefings, Compliance impact analysis, Advisory integration, Enforcement monitoring, Standards updates
12 month delivery

Features	Small $8,000 /total	Medium $40,000 /total	Large $144,000 /total
EU AI Act Risk Classification & Obligation Mapping	AI system inventory, Risk tier classification, High-risk identification, Deployer obligations, Compliance gaps, Priority roadmap, Annex III assessment, Senior advisor, Obligation map	Portfolio assessment, Full obligation mapping, Governance foundation, Risk architecture, Deployer requirements, Classification register, EU AI Act alignment, Prohibited practice screening	Continuous classification, New system review, Portfolio tracking, Regulatory integration, Ongoing obligation mapping, Register maintenance, Enforcement alert, Annual reassessment, new deployment check
High-Risk AI System Governance Design	Not included.	Human oversight design, Monitoring procedures, Incident reporting, Documentation requirements, Deployer architecture, Accountability mapping, Oversight role assignments, Intervtion criteria	Governance maintenance, Oversight reviews, Incident management, Role updates, Procedure updates, Intervention tracking, Documentation maintenance, Regulatory integration, Annual governance review
Human Oversight Framework & Accountability Design	Not included.	Oversight role design, Intervention criteria, Escalation procedures, Competency requirements, Accountability mapping, Decision review framework, Oversight documentation, Human-in-the-loop	Program management, Effectiveness monitoring, Role updates, Competency gap tracking, Intervention review, Escalation effectiveness, Accountability audits, Oversight KPIs, Quarterly reviews
AI QMS Integration & Algorithmic Audit Readiness	Audit readiness review, Evidence gaps, Documentation weaknesses, Oversight gaps, Pre-scrutiny review, Readiness scoring, Quick wins, AI governance snapshot, Customer audit prep, senior advisor asses	QMS integration, Model oversight connection, CAPA loop integration, Audit program alignment, Documentation control, Operational system design, Algorithmic audit program, Evidenence architecture	Ongoing readiness, Evidence management, QMS reviews, Inspection preparation, Customer audit support, Audit facilitation, Evidence updates, Trend analysis, Continuous monitoring, annual program review
EU AI Act Regulatory Monitoring & Compliance Updates	Not included.	Not included.	Monthly enforcement updates, Guidance tracking, Emerging obligations, Regulatory briefings, Compliance impact analysis, Advisory integration, Enforcement monitoring, Standards updates

Small $8,000 /total
EU AI Act Risk Classification & Obligation Mapping	AI system inventory, Risk tier classification, High-risk identification, Deployer obligations, Compliance gaps, Priority roadmap, Annex III assessment, Senior advisor, Obligation map
High-Risk AI System Governance Design	Not included.
Human Oversight Framework & Accountability Design	Not included.
AI QMS Integration & Algorithmic Audit Readiness	Audit readiness review, Evidence gaps, Documentation weaknesses, Oversight gaps, Pre-scrutiny review, Readiness scoring, Quick wins, AI governance snapshot, Customer audit prep, senior advisor asses
EU AI Act Regulatory Monitoring & Compliance Updates	Not included.

Medium $40,000 /total
EU AI Act Risk Classification & Obligation Mapping	Portfolio assessment, Full obligation mapping, Governance foundation, Risk architecture, Deployer requirements, Classification register, EU AI Act alignment, Prohibited practice screening
High-Risk AI System Governance Design	Human oversight design, Monitoring procedures, Incident reporting, Documentation requirements, Deployer architecture, Accountability mapping, Oversight role assignments, Intervtion criteria
Human Oversight Framework & Accountability Design	Oversight role design, Intervention criteria, Escalation procedures, Competency requirements, Accountability mapping, Decision review framework, Oversight documentation, Human-in-the-loop
AI QMS Integration & Algorithmic Audit Readiness	QMS integration, Model oversight connection, CAPA loop integration, Audit program alignment, Documentation control, Operational system design, Algorithmic audit program, Evidenence architecture
EU AI Act Regulatory Monitoring & Compliance Updates	Not included.

Large $144,000 /total
EU AI Act Risk Classification & Obligation Mapping	Continuous classification, New system review, Portfolio tracking, Regulatory integration, Ongoing obligation mapping, Register maintenance, Enforcement alert, Annual reassessment, new deployment check
High-Risk AI System Governance Design	Governance maintenance, Oversight reviews, Incident management, Role updates, Procedure updates, Intervention tracking, Documentation maintenance, Regulatory integration, Annual governance review
Human Oversight Framework & Accountability Design	Program management, Effectiveness monitoring, Role updates, Competency gap tracking, Intervention review, Escalation effectiveness, Accountability audits, Oversight KPIs, Quarterly reviews
AI QMS Integration & Algorithmic Audit Readiness	Ongoing readiness, Evidence management, QMS reviews, Inspection preparation, Customer audit support, Audit facilitation, Evidence updates, Trend analysis, Continuous monitoring, annual program review
EU AI Act Regulatory Monitoring & Compliance Updates	Monthly enforcement updates, Guidance tracking, Emerging obligations, Regulatory briefings, Compliance impact analysis, Advisory integration, Enforcement monitoring, Standards updates

Locations (1)

2604 Whittier Pl Wilmington, DE, United States 19808

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