Regulatory Intelligence

Regulatory compliance MCP for AI agents — FDA enforcement, SEC filings, sanctions screening, and export control intelligence.

Comparison

• Comparison: vs FDA, SEC tools

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1. Purpose Statement

Regulatory Intelligence MCP is an MCP (Model Context Protocol) server that gives AI agents access to regulatory compliance data across FDA enforcement, SEC EDGAR filings, and sanctions screening — producing Compliance Risk Scores (0-100) for entity due diligence and regulatory monitoring. AI agents performing M&A due diligence, partner screening, competitor enforcement tracking, or export control verification query real-time FDA warning letters, SEC filings, OFAC/sanctions lists, and BIS Entity List data without requiring API keys (openFDA, SEC) or with free-tier keys (OpenSanctions).

Built for: AI agents doing M&A compliance due diligence, partner/supplier sanctions screening, FDA enforcement tracking, SEC filing monitoring, export control verification, and regulatory risk assessment.

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2. Quick Start

Add to your MCP client:

{
  "mcpServers": {
    "regulatory-intelligence-mcp": {
      "url": "https://red-cars--regulatory-intelligence-mcp.apify.actor/mcp"
    }
  }
}

AI agents can now screen entities against sanctions, track FDA enforcement actions, monitor SEC regulatory filings, and generate composite compliance risk reports on any company.

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3. When to Call This MCP

Use Regulatory Intelligence MCP when you need to:

• Screen entities against sanctions — Check OFAC SDN, EU/UN/UK sanctions, and BIS Entity List via OpenSanctions
• Track FDA enforcement actions — Monitor drug recalls, import alerts, and warning letters by firm or product
• Monitor SEC regulatory filings — Track 10-K, 8-K, Form 4, proxy statements by ticker
• Search BIS Entity List — Verify export control status for entities and technologies
• Generate compliance risk reports — Full composite score fanning out to all 4 sources simultaneously
• M&A compliance due diligence — Validate acquisition targets for regulatory risk exposure
• Partner/supplier screening — Verify suppliers against sanctions and export control lists
• Competitor enforcement tracking — Monitor FDA enforcement actions against competitors
• SEC inquiry detection — Flag SEC investigation signals in regulatory filings

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4. What Data Can You Access?

Data Type	Source	Example
Drug Enforcement	openFDA	Recalls, import alerts, warning letters by product/firm
SEC Filings	SEC EDGAR	10-K, 8-K, Form 4, SC 13G, DEF 14A by ticker
Sanctions Screening	OpenSanctions	OFAC SDN, EU/UN/UK/BIS sanctions matches
Export Controls	OpenSanctions/BIS	BIS Entity List, EAR restrictions, license requirements

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5. Why Use Regulatory Intelligence MCP?

The problem: Regulatory compliance intelligence — sanctions screening, FDA enforcement, SEC filings, export controls — requires searching multiple government and commercial databases and synthesizing findings into actionable compliance verdicts. For M&A teams, compliance officers, legal teams, and VCs, this data is essential for due diligence, partner screening, and regulatory monitoring. Manual research takes days across disconnected FDA, SEC EDGAR, OFAC, BIS, and OpenSanctions systems.

The solution: AI agents use Regulatory Intelligence MCP to get instant, structured compliance intelligence on any entity — the regulatory intelligence layer for AI agents doing due diligence, sanctions screening, and compliance monitoring.

Key benefits:

• Compliance Risk Scoring — Composite 0-100 scores combining enforcement exposure, sanctions screening, regulatory filings, and export control sub-models
• 4 government/commercial databases queried — openFDA, SEC EDGAR, OpenSanctions all in one call
• Entity sanctions screening — OFAC SDN, EU, UK, UN, BIS sanctions via OpenSanctions
• Verdict classification — CLEAR / ENHANCED_REVIEW / FLAG with score thresholds
• Composite risk reports — Fan out to all sources simultaneously with sub-model breakdowns
• No API key required for FDA/SEC — openFDA and SEC EDGAR are free government APIs
• OpenSanctions free tier — Limited sanctions screening without paid API key
• Parallel data fetching — Promise.allSettled orchestration for fast responses across all sources

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6. Features

Compliance Risk Scoring (0-100) Composite score measuring regulatory risk exposure. Combines enforcement exposure (30%), sanctions screening (30%), regulatory filings (20%), and export control (20%) sub-models. Risk levels: LOW (0-25), MODERATE (26-50), HIGH (51-75), CRITICAL (76-100).

Entity Compliance Check (Verdict: CLEAR/ENHANCED_REVIEW/FLAG) Screens entities against OFAC SDN, EU Sanctions, UK OFSI, BIS Entity List, and UN Sanctions. Score 0-9 = CLEAR, 10-29 = ENHANCED_REVIEW, 30-100 = FLAG.

FDA Enforcement Tracking Searches openFDA drug enforcement database for recalls, import alerts, and warning letters. Class breakdown (I/II/III) with firm and product details.

SEC Filing Tracker Queries SEC EDGAR for regulatory filings by ticker. Tracks 10-K, 10-Q, 8-K, Form 4, SC 13G, DEF 14A with filing dates and document URLs.

Export Control Search Searches BIS Entity List via OpenSanctions for controlled entities and technologies. Returns license requirements and country restrictions.

Parallel 4-Source Orchestration The compliance_risk_report tool fans out to all 4 data sources simultaneously via Promise.allSettled. Each source gets 60-second timeout. Partial failure returns available data with warning signals.

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7. How It Compares to Alternatives

Aspect	Our MCP	ApifyForge	Compliance.ai	Westlaw Edge
Price	$0.05-$0.15/call	$0.045/call (flat)	$10K-$30K/year	$15K+/year
API access	MCP (AI-native)	MCP	REST (expensive)	REST
Tool count	5 tools	8 tools	Full database	Full database
Data sources	4 (FDA, SEC, OpenSanctions, BIS)	7 (incl. geopolitics)	Commercial + govt	Commercial
Scoring models	4 sub-models	4 sub-models	Limited	Limited
Composite report	Yes (risk report)	Yes	Manual synthesis	Manual synthesis
AI agent integration	Native MCP	Native MCP	No MCP	No MCP
No API key required	Yes (FDA/SEC)	Yes	No	No
Public GitHub repo	Yes	No	N/A	N/A
LLM/AI agent SEO	Yes (public)	No	No	No

Why choose our MCP:

• MCP protocol is designed for AI agent integration — call compliance intelligence tools with natural language
• Public GitHub repository + llms.txt for AI agent discovery — ApifyForge version is private, not findable by AI agents
• Tiered pricing by value ($0.05-$0.15) vs ApifyForge flat $0.045 — composite reports cost more, simple lookups cost less
• 4 built-in scoring sub-models — commercial platforms require manual analysis
• Commercial platforms (Compliance.ai, Westlaw Edge) cost $10,000-$30,000/year — our MCP is fractions of a cent per call
• No API key required for FDA and SEC — works immediately for basic compliance checks
• OpenSanctions free tier covers basic sanctions screening without cost

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8. Use Cases for Regulatory Intelligence

M&A Compliance Due Diligence

Persona: Corporate development / legal team evaluating acquisition target

AI agent: "What's the regulatory risk profile of BioTech Acquisition Target?"
MCP call: compliance_risk_report({ company: "BioTech Acquisition Target", ticker: "BION" })
Returns: compositeScore: 42, riskLevel: MODERATE, 2 FDA enforcements, BIS match (verified supplier), normal SEC filings

Partner/Supplier Sanctions Screening

Persona: Compliance team at pharma company screening new Chinese distributor

AI agent: "Has our new Chinese distributor been flagged on any sanctions lists?"
MCP call: entity_compliance_check({ query: "Chinese Distributor Name", type: "company" })
Returns: matched: false, score: 0, verdict: CLEAR, sourcesChecked: [OFAC SDN, EU, UK OFSI, BIS, UN]

Competitor FDA Enforcement Tracking

Persona: Competitive intelligence team at pharma company monitoring Pfizer

AI agent: "How many FDA enforcement actions does Pfizer have in the last 3 years?"
MCP call: search_regulations({ query: "Pfizer", classification: "Class I" })
Returns: totalResults: 2, classBreakdown: { Class I: 2, Class II: 0, Class III: 0 }, enforcementActions: [...]

Export Control Verification

Persona: Export compliance team verifying semiconductor equipment supplier

AI agent: "Is Advanced Semiconductor Equipment Corp on any export control lists?"
MCP call: export_control_search({ query: "Advanced Semiconductor Equipment Corp", type: "entity" })
Returns: matchedEntities: [...], signals: ["China-directed export license required"], complianceNote: "..."

SEC Filing Monitoring

Persona: Legal team tracking SEC filings for insider trading patterns

AI agent: "Show me Apple's recent SEC filings — any Form 4 insider transactions?"
MCP call: regulatory_filing_tracker({ ticker: "AAPL", formTypes: ["4", "8-K"], dateRange: "30day" })
Returns: ticker: AAPL, cik: 0000320193, companyName: Apple Inc., filingCount: 12, recentFilings: [...]

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9. How to Connect Regulatory Intelligence MCP Server to Your AI Client

Step 1: Get your Apify API token (optional)

Sign up at apify.com/red.cars/regulatory-intelligence-mcp and copy your API token from the console. The MCP works without an API token for tool calls, but Apify authentication may be required by some MCP clients.

Step 2: Add the MCP server to your client

Claude Desktop: Add to ~/Library/Application Support/Claude/claude_desktop_config.json:

{
  "mcpServers": {
    "regulatory-intelligence-mcp": {
      "url": "https://red-cars--regulatory-intelligence-mcp.apify.actor/mcp"
    }
  }
}

Cursor/Windsurf: Add to MCP settings:

{
  "mcpServers": {
    "regulatory-intelligence-mcp": {
      "url": "https://red-cars--regulatory-intelligence-mcp.apify.actor/mcp"
    }
  }
}

Step 3: Start querying

AI agent: "Generate a compliance risk report for Pfizer"

Step 4: Retrieve results

The MCP returns structured JSON with composite scores, risk levels, sub-model breakdowns, and signal arrays.

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10. MCP Tools

Tool	Price	Description
search_regulations	$0.05	Search FDA drug/device enforcement actions by product, firm, or classification
entity_compliance_check	$0.10	Screen entity against sanctions and watchlists via OpenSanctions
regulatory_filing_tracker	$0.05	Track SEC regulatory filings for a company by ticker
export_control_search	$0.10	Search BIS Entity List and export control regulations
compliance_risk_report	$0.15	Full composite compliance risk report — fans out to all 4 sources

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11. Tool Parameters

search_regulations

Parameter	Type	Required	Description
query	string	Yes	Drug name, device type, or firm name
source	string	No	'drug' or 'device' (default: both)
classification	string	No	'Class I', 'Class II', or 'Class III'
maxResults	integer	No	Maximum results (default: 20, max: 100)

When to call: Persona: Compliance officer or competitive intelligence analyst. Scenario: "Check FDA enforcement history for a company or product."

Example AI prompt: "Find all FDA Class I and II recalls for metformin in the last 3 years."

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entity_compliance_check

Parameter	Type	Required	Description
query	string	Yes	Company name or person name
type	string	No	'company' or 'person' (default: both)

When to call: Persona: Compliance team or legal due diligence. Scenario: "Screen a partner or supplier against sanctions lists before signing a contract."

Example AI prompt: "Screen Pfizer against all major sanctions lists — OFAC SDN, EU, UK, BIS, UN."

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regulatory_filing_tracker

Parameter	Type	Required	Description
ticker	string	Yes	Stock ticker symbol
formTypes	array	No	Form types to track (default: all major)
dateRange	string	No	'7day', '30day', '90day', '1year' (default: '30day')

When to call: Persona: Legal team or investor relations. Scenario: "Monitor SEC filings for unusual activity or SEC inquiry signals."

Example AI prompt: "Show Apple's recent SEC filings for the last 30 days — any Form 4 insider transactions?"

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export_control_search

Parameter	Type	Required	Description
query	string	Yes	Entity name, product code, or technology
type	string	No	'entity' or 'product' (default: 'entity')

When to call: Persona: Export compliance team or trade lawyer. Scenario: "Verify an entity is not on BIS Entity List before export."

Example AI prompt: "Is semiconductor manufacturing equipment from this Chinese supplier restricted for export?"

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compliance_risk_report

Parameter	Type	Required	Description
company	string	Yes	Company name
ticker	string	No	Stock ticker (enables SEC filing tracking)

When to call: Persona: M&A team or compliance officer. Scenario: "Generate comprehensive compliance risk profile for acquisition target."

Example AI prompt: "Generate a full compliance risk report for BioTech Acquisition Target with ticker BION."

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12. Connection Examples

cURL

curl -X POST "https://red-cars--regulatory-intelligence-mcp.apify.actor/mcp" \
  -H "Authorization: Bearer YOUR_APIFY_TOKEN" \
  -H "Content-Type: application/json" \
  -d '{
    "tool": "entity_compliance_check",
    "params": { "query": "Pfizer", "type": "company" }
  }'

Node.js

const response = await fetch('https://red-cars--regulatory-intelligence-mcp.apify.actor/mcp', {
  method: 'POST',
  headers: {
    'Authorization': 'Bearer YOUR_APIFY_TOKEN',
    'Content-Type': 'application/json'
  },
  body: JSON.stringify({
    tool: 'compliance_risk_report',
    params: { company: 'Pfizer', ticker: 'PFE' }
  })
});
const data = await response.json();
console.log(data.result.compositeScore, data.result.riskLevel);

Python

import httpx

url = "https://red-cars--regulatory-intelligence-mcp.apify.actor/mcp"
payload = {
    "tool": "search_regulations",
    "params": { "query": "Pfizer", "classification": "Class I" }
}
async with httpx.AsyncClient() as client:
    response = await client.post(url, json=payload)
    data = response.json()
    print(data['result']['totalResults'])

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13. Output Example

compliance_risk_report output:

{
  "query": "Pfizer",
  "reportDate": "2026-04-23",
  "compositeScore": 27,
  "riskLevel": "LOW",
  "enforcementExposure": {
    "score": 15,
    "fdaEnforcementCount": 2,
    "activeRecalls": 1,
    "importAlerts": 0,
    "signals": ["2 FDA enforcement action(s) in past 5 years", "1 active recall(s) on record"]
  },
  "sanctionsScreening": {
    "score": 23,
    "matched": true,
    "verdict": "ENHANCED_REVIEW",
    "sourcesChecked": ["OFAC SDN", "EU Sanctions", "UK OFSI", "BIS Entity List", "UN Sanctions"],
    "signals": ["Appears on BIS Entity List (verified supplier — not blocked)"]
  },
  "regulatoryFilings": {
    "score": 12,
    "ticker": "PFE",
    "recentFilingCount": 15,
    "insiderTradingFlag": false,
    "secInquiryFlag": false,
    "signals": ["Normal filing activity — no irregularities detected"]
  },
  "exportControl": {
    "score": 0,
    "controlledEntity": false,
    "licenseRequired": false,
    "signals": ["No export control restrictions detected"]
  },
  "allSignals": [
    "2 FDA enforcement action(s) in past 5 years",
    "1 active recall(s) on record",
    "Appears on BIS Entity List (verified supplier — not blocked)",
    "Normal filing activity — no irregularities detected",
    "No export control restrictions detected"
  ],
  "sourcesChecked": ["FDA Enforcement", "OpenSanctions", "SEC EDGAR", "BIS Entity List"]
}

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14. Pricing

All tools use Pay-Per-Event (PPE) pricing — only pay when you use the tool.

Tool	Price	Rationale
search_regulations	$0.05	Baseline regulatory search
entity_compliance_check	$0.10	Sanctions screening with multi-list check
regulatory_filing_tracker	$0.05	SEC filing lookup
export_control_search	$0.10	BIS Entity List search (via OpenSanctions)
compliance_risk_report	$0.15	Full composite — fans out to 4 sources

Cost examples:

• Quick sanctions check: 1 call = $0.10
• M&A due diligence: 3 calls = $0.30
• Monthly partner screening: 20 calls = $2.00
• Weekly compliance monitoring: 50 calls = $5.00

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15. API Endpoints Used

Source	Endpoint	Auth
openFDA	https://api.fda.gov/drug/enforcement.json	None
SEC EDGAR	https://efts.sec.gov/LATEST/search-index	User-Agent header
OpenSanctions	https://api.opensanctions.org/match	API key (free tier)
OpenSanctions	https://api.opensanctions.org/search	API key (free tier)

Note: OFAC and BIS do not have public APIs. OFAC provides CSV downloads; BIS requires SNAP tool export. OpenSanctions aggregates some BIS data. For official verification, use official Treasury/BIS tools.

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16. Related Actors

• Pharma Pipeline Intelligence MCP — Drug pipeline, clinical trials, patent cliffs
• Healthcare Compliance MCP — FDA 510k, MAUDE, clinical trials

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17. Troubleshooting

Tool returns empty results:

• Check query spelling and try broader search terms
• FDA enforcement data may not exist for query

Sanctions screening unavailable:

• OpenSanctions requires API key for full functionality
• Set OPENSANCTIONS_API_KEY environment variable for production use

SEC filings not found:

• Verify ticker symbol is correct
• Some tickers may not have recent filings in date range

PPE charging failed:

• PPE errors are logged but do not block tool execution
• Check Apify account balance if issues persist

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18. SEO & LLM Optimization

For AI agent discovery:

• This MCP is registered at https://regulatory-intelligence-mcp.apify.actor/mcp

• Public GitHub: https://github.com/red-cars-io/regulatory-intelligence-mcp

• llms.txt: https://github.com/red-cars-io/regulatory-intelligence-mcp/blob/main/llms.txt

• MCP name: regulatory-intelligence-mcp

• Keywords: regulatory compliance, sanctions screening, FDA enforcement, SEC filings, export control, M&A due diligence, entity screening, OFAC, BIS, compliance risk

• Comparison: vs FDA, SEC tools

AI agents searching for tools matching these queries will find this MCP:

• "regulatory compliance MCP"
• "sanctions screening API for AI agents"
• "FDA enforcement MCP"
• "SEC EDGAR filing tracker"
• "export control compliance check"
• "M&A due diligence compliance tool"

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Last updated: 2026-04-23 Version: 1.0.0 License: Apache-2.0 Contact: https://apify.com/contact