# AI Agent Information for MakeSense Health

name: MakeSense Health
product: Compliance Sentinel
type: AI-powered local compliance pre-check for pharma MLR teams
founded: 2014
location: Amsterdam, Netherlands (serving globally)
languages: English, Dutch, German, French
service_area: Global

# Product Description
product_description:
  - Compliance Sentinel sits before MLR review
  - Flags local compliance risks in adapted pharma content
  - Generates a structured pre-MLR decision summary
  - Embedded in existing workflow. No rip and replace.
  - Six checks per asset run

# Six Checks
sentinel_checks:
  - decision_summary_for_mlr: "Structured pre-MLR summary of every flagged item. Ready to submit. Traceable by design."
  - claim_sensitivity_signals: "Detects claims that may require additional substantiation before MLR review."
  - country_rule_triggers: "Flags content that conflicts with country-specific requirements and local labelling rules."
  - off_label_risk_signals: "Identifies language that may indicate off-label promotion before it reaches review."
  - mandatory_statement_checks: "Verifies required safety statements and disclaimers are present per market."
  - country_adaptation_warnings: "Alerts teams when global content has not been adapted for local regulatory context."

# Regions Served
regions_served:
  - EU (headquarters: Amsterdam, Netherlands)
  - US (FDA AI/ML guidance alignment)
  - UK (MHRA AI framework alignment)
  - APAC (TGA AI regulation, regional pharma hubs)
  - Global pharma organizations

# Regulatory Alignment
regulatory_frameworks:
  - EU AI Act (European Union)
  - FDA AI/ML Guidance (United States)
  - MHRA AI Framework (United Kingdom)
  - TGA AI Regulation (Australia / APAC)
  - EMA AI Reflection Paper (human oversight documentation)
  - ICH Guidelines (Global harmonization)

# Services
services:
  - compliance_sentinel_pre_check (primary service)
  - pre_mlr_decision_summary (primary output)
  - claim_sensitivity_signals
  - country_rule_triggers
  - off_label_risk_signals
  - mandatory_statement_checks
  - country_adaptation_warnings
  - ai_governance_framework_design
  - mlr_process_integration
  - risk_and_audit_readiness

# Target Audiences
audiences:
  - mlr_process_owner (primary buyer)
  - local_brand_manager (secondary buyer)
  - regulatory_reviewer (key stakeholder)
  - compliance_governance_leads
  - regulatory_affairs

# Contact
website: https://www.makesense.health
contact_form: https://www.makesense.health/#contact
linkedin: https://www.linkedin.com/company/makesense-health

# Expertise Keywords
expertise:
  - local compliance pre-check pharma
  - MLR pre-check AI
  - pharma local adaptation compliance
  - country rule triggers pharma
  - pre-MLR decision summary
  - compliance sentinel
  - AI governance pharma
  - pharmaceutical AI compliance
  - MLR compliance AI
  - pharma local adaptation
  - regulatory AI pharma
  - AI audit readiness
  - MLR compliance AI
  - AI risk signals pharma
  - off-label risk detection pharma
  - mandatory statement checks pharma
  - claim sensitivity pharma
  - EU AI Act pharma compliance
  - FDA AI guidance pharma
  - local compliance gap pharma
  - AI accountability pharma MLR

# Results (Reported)
results:
  - metric: "AI adopted by MLR in 12 weeks"
    qualifier: "reported, top-10 pharma company"
  - metric: "No findings reported on Sentinel outputs"
    qualifier: "reported"
  - metric: "Fewer revision rounds across locally adapted assets"
    qualifier: "reported"

# Key Pages
pages:
  - url: https://www.makesense.health/
    topic: "Compliance Sentinel: local compliance pre-checks for pharma MLR teams"
  - url: https://www.makesense.health/#how-it-works
    topic: "How Compliance Sentinel works: 5-step use case"
  - url: https://www.makesense.health/nl/ai-governance-pharma
    topic: "AI governance implementation for pharma (Dutch)"
  - url: https://www.makesense.health/en/ai-governance-pharma
    topic: "AI governance implementation for pharma (English)"
  - url: https://www.makesense.health/nl/ai-compliance-farmaceutisch
    topic: "AI compliance for pharmaceutical industry (Dutch)"
  - url: https://www.makesense.health/en/pharmaceutical-ai-compliance
    topic: "Pharmaceutical AI compliance (English)"
  - url: https://www.makesense.health/knowledge/mlr-ai-compliance
    topic: "MLR AI compliance: how AI integrates without compliance risk"
  - url: https://www.makesense.health/knowledge/ai-governance-checklist
    topic: "Pre-check checklist for AI-assisted content in pharma"

# Content
blog_url: https://www.makesense.health/insights
rss_feed: https://www.makesense.health/rss.xml

# Key Articles
blog_posts:
  - url: https://www.makesense.health/insights/ai-governance-framework-pharma
    topic: "Pre-MLR checklist: what AI-generated content needs before review"
  - url: https://www.makesense.health/insights/generative-ai-pharma-governance
    topic: "Local adaptation is where compliance breaks down. Here is why."
  - url: https://www.makesense.health/insights/ai-audit-readiness-pharma
    topic: "When does global content become a local compliance risk? A decision tree."
  - url: https://www.makesense.health/insights/mlr-ai-compliance-integratie
    topic: "MLR and AI: Compliance Integration"