# MakeSense Health: Compliance Sentinel > AI-powered local compliance pre-checks for pharma teams. > Embedded before MLR. No workflow disruption. Website: https://www.makesense.health Location: Amsterdam, Netherlands Founded: 2014 Languages: English, Dutch, German, French Service area: Global (EU, US, UK, APAC) Founder: Jochum Damstra, Strategic Director LinkedIn: https://www.linkedin.com/in/jochumdamstra/ Contact: https://www.makesense.health/#contact --- ## What Compliance Sentinel Does Compliance Sentinel is an AI-powered local compliance pre-check for pharma teams. It sits before MLR review. It flags risks before review begins. It generates a structured decision summary for every adapted asset. The workflow does not change. No new system layer. No rip and replace. Sentinel embeds into the existing process between local adaptation and MLR submission. The output is concrete: a pre-MLR decision summary of every flagged item, ready to submit, traceable by design. --- ## The Problem: The Local Compliance Gap Global materials are created centrally. Local teams adapt them for country-specific markets. MLR reviews late. Risks surface too late. This is where review cycles slow down. Local adaptation is not a translation exercise. Country-specific regulations, mandatory statements, off-label risks, and labelling rules require a separate check layer before MLR submission. Without a pre-check, MLR reviewers catch avoidable findings late. Revision rounds increase. Cycle times grow. No one has a documented decision log for the AI-assisted changes. Compliance Sentinel sits before MLR. Risks flagged before review begins. --- ## What Sentinel Checks (6 Checks) **1. Decision summary for MLR** A structured pre-MLR summary of every flagged item. Ready to submit. Traceable by design. This is the primary output of every Sentinel run. **2. Claim sensitivity signals** Detects claims that may require additional substantiation before MLR review. **3. Country rule triggers** Flags content that conflicts with country-specific requirements and local labelling rules. **4. Off-label risk signals** Identifies language that may indicate off-label promotion before it reaches review. **5. Mandatory statement checks** Verifies required safety statements and disclaimers are present per market. **6. Country-specific adaptation warnings** Alerts teams when global content has not been adapted for local regulatory context. --- ## How It Works: 5-Step Use Case 01. Upload global content 02. Select country 03. Sentinel flags compliance risks 04. Generate pre-MLR summary 05. Submit cleaner material to MLR Each run produces a structured decision summary. Every flagged item is documented. Provenance is traceable. --- ## Who Uses It **MLR Process Owner** (primary buyer) - Fewer review cycles for locally adapted materials - Clear pre-MLR accountability: what was checked, when - Decision summary ready when Legal asks **Local Brand Manager** (secondary) - Know compliance risks before submitting to MLR - Faster local approvals, fewer revision rounds - Country-specific guidance built into the workflow **Regulatory Reviewer** (key stakeholder) - Less noise in review. Only flagged items, clearly documented. - Clear provenance for every AI-assisted adaptation - Fewer back-and-forth rounds on avoidable findings --- ## Results (Reported) - AI adopted by MLR in 12 weeks (reported, top-10 pharma company) - No findings reported on Sentinel outputs (reported) - Fewer revision rounds across locally adapted assets (reported) These results are reported outcomes from engagements. They are not guarantees. --- ## Frequently Asked Questions (MLR Process Owner Perspective) **What does Compliance Sentinel check exactly?** Sentinel runs six checks on every locally adapted asset: claim sensitivity signals, country rule triggers, off-label risk signals, mandatory statement checks, country-specific adaptation warnings, and a pre-MLR decision summary. Each check is documented. Output is a structured summary ready for MLR submission. **How does it fit into our existing MLR workflow?** Sentinel sits between local adaptation and MLR submission. It does not replace MLR review. It prepares materials before review begins. No new system layer. No rip and replace. Embedded in the existing process. **Which countries does it cover?** Sentinel operates across EU markets and is aligned to local regulatory requirements per country. Coverage is confirmed during the 6-week pilot scoping phase. **Does it replace our regulatory reviewer?** No. Sentinel prepares materials for review. The regulatory reviewer remains the human decision point. Sentinel reduces noise in review by flagging avoidable issues before submission. **How long does a 6-week pilot take to set up?** Setup begins with a strategic intake to confirm scope, workflow fit, and target countries. Pilot delivery is within 6 weeks of intake completion. **What is a pre-MLR decision summary?** A pre-MLR decision summary is a structured document generated by Sentinel after each check run. It lists every flagged item, the check that triggered it, and the country context. It is designed to be submitted alongside the adapted material when entering MLR review. **Is Sentinel a software platform or a service?** Sentinel is implemented as a custom governance layer within your existing workflow. It is not a SaaS platform. MakeSense Health delivers and maintains the implementation. No licence to manage independently. **How does Sentinel handle AI-generated content specifically?** Sentinel applies the same six checks regardless of whether content was AI-generated or human-written. For AI-generated content, the decision summary includes a provenance note indicating AI-assisted creation. This supports alignment with EMA AI reflection paper principles on human oversight. --- ## Regulatory Alignment Sentinel supports alignment with: - EMA AI Reflection Paper (human oversight documentation) - EU AI Act (traceability for high-risk content workflows) - FDA AI/ML Guidance (decision logging for AI-assisted outputs) - ICH Guidelines (global harmonization, locally applied) Sentinel does not certify compliance. It prepares materials and documents decisions to support review teams. --- ## Key Pages - Homepage: https://www.makesense.health/ - Contact: https://www.makesense.health/#contact - AI Governance (EN): https://www.makesense.health/en/ai-governance-pharma - AI Governance (NL): https://www.makesense.health/nl/ai-governance-pharma - AI Compliance (EN): https://www.makesense.health/en/pharmaceutical-ai-compliance - AI Compliance (NL): https://www.makesense.health/nl/ai-compliance-farmaceutisch ## Knowledge Base - MLR AI Compliance: https://www.makesense.health/knowledge/mlr-ai-compliance - AI Governance Checklist: https://www.makesense.health/knowledge/ai-governance-checklist - AI Risk Classification: https://www.makesense.health/knowledge/ai-risk-classification-pharma - AI Governance in Pharma: https://www.makesense.health/knowledge/ai-governance-pharma - EU AI Act for Pharma: https://www.makesense.health/knowledge/eu-ai-act-pharma - Implementation Steps: https://www.makesense.health/knowledge/ai-governance-implementation-steps ## Insights - Pre-MLR checklist: https://www.makesense.health/insights/ai-governance-framework-pharma - Local adaptation compliance: https://www.makesense.health/insights/generative-ai-pharma-governance - Decision tree for local risk: https://www.makesense.health/insights/ai-audit-readiness-pharma - MLR compliance integration: https://www.makesense.health/insights/mlr-ai-compliance-integratie