GxP Regulations MCP

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One endpoint, one OAuth signup, access from any MCP-compatible client.

Connect

Claude Code (one line):

claude mcp add ansvar --transport http https://gateway.ansvar.eu/mcp

Claude Desktop / Cursor — add to claude_desktop_config.json (or mcp.json):

{
  "mcpServers": {
    "ansvar": {
      "type": "url",
      "url": "https://gateway.ansvar.eu/mcp"
    }
  }
}

Claude.ai — Settings → Connectors → Add custom connector → paste https://gateway.ansvar.eu/mcp

First request opens an OAuth flow at ansvar.eu/gateway. After signup, your client is bound to your account; tier (free / premium / team / company) determines fan-out, quota, and which downstream MCPs are reachable.

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Self-host this MCP

You can also clone this repo and build the corpus yourself. The schema, fetcher, and tool implementations all live here. What is not in the repo is the pre-built database — TDM and standards-licensing constraints on the upstream sources mean we host the corpus on Ansvar infrastructure rather than redistribute it as a public artifact.

Build your own: run this repo's ingestion script (entry-point varies per repo — typically scripts/ingest.sh, npm run ingest, or make ingest; check the repo root).

An MCP (Model Context Protocol) server providing search and retrieval tools for GxP pharmaceutical regulations — EudraLex GMP, GVP, GDP, US cGMP (21 CFR), and ICH GCP.

Installation

stdio (local)

Configure your MCP client:

HTTP (remote)

Use the hosted endpoint configured in server.json.

Docker

docker pull ghcr.io/ansvar-systems/gxp-regulations-mcp:latest
docker run -p 8080:8080 ghcr.io/ansvar-systems/gxp-regulations-mcp:latest

Tools

12 tools are available. See TOOLS.md for full parameter reference.

Tool	Description
search_gxp	Full-text search across all GxP regulations
search_cfr_pharma	Search US FDA 21 CFR pharmaceutical regulations
get_gmp_section	Retrieve a specific GMP section by source and number
get_gvp_module	Retrieve a GVP module by Roman numeral
get_gdp_section	Retrieve a GDP section by number
get_gcp_section	Retrieve a GCP section (ICH E6 R3 or CFR 312)
compare_gmp	Compare GMP requirements across jurisdictions
build_regulatory_stance	Aggregate regulatory stance on a topic across all sources
list_gvp_modules	List available GVP modules
list_sources	List all loaded regulatory sources
check_data_freshness	Report corpus snapshot date and staleness
about	Server version and capability summary

Data Coverage

Covers 7 regulations, 29 sections across GMP, GVP, GDP, and GCP. See COVERAGE.md for what is and is not included.

Note: This server serves a frozen corpus (snapshot: 2026-03-26). Content is summarised for MCP delivery — always verify exact wording against official publications from EMA, FDA, ICH, and PIC/S.

Endpoint Configuration

See server.json for transport options (stdio and streamable-http).

License

Apache 2.0 — see LICENSE.