Regulatory MCP Server

A regulatory-affairs layer for ADK-Rust Enterprise agents across energy, food & beverage, legal, and pharmaceuticals. 27 MCP tools spanning requirements, compliance reviews (with artifact screening), submissions/filings, regulatory-change monitoring, and change control.

What It Does

The spine is requirements (the rules) → compliance reviews that check artifacts against them → submissions to authorities, plus change monitoring and change control. One model serves all 7 agents.

| Domain | Agents this server backs | |--------|--------------------------| | Energy & Utilities | Rate Case Evidence Builder | | Food & Beverage | Allergen Label Review · Nutritional Claims Reviewer | | Legal | Policy Compliance Reviewer · Regulatory Change Monitor | | Pharmaceuticals | CMC Change Control · Regulatory Submission Builder |

Architecture

Regulatory MCP Architecture

Key Mechanics

Artifact screening — auto_screen matches an artifact's text against active requirements' keywords and seeds advisory findings ("this references a topic governed by 21 CFR 101.4 — verify"). A heuristic aid, not a compliance determination.
Review gating — a review can't be completed while open critical/major findings remain; the verdict (compliant / compliant-with-conditions / non-compliant) is derived if not supplied.
Submission gating — a filing can only be submit-ted once it has dossier sections and every section is complete. Filing to an authority is classed external_write.
Change-control interlock — a change control must have its reportability assessed before a decision, and a prior-approval change can only be marked implemented once its linked submission is Approved.

Tools (27)

Requirements (3)

add_requirement · get_requirement · search_requirements

Compliance Reviews (7)

create_review · get_review · search_reviews · auto_screen · add_finding · set_finding_disposition · complete_review (gated)

Submissions / Filings (7)

create_submission · get_submission · search_submissions · add_section · set_section_complete · submit (gated, external) · record_determination (gated)

Regulatory Change Monitoring (4)

log_change · get_change · search_changes · assess_change

Change Control (6)

open_change_control · get_change_control · assess_reportability · link_submission · decide_change_control (gated) · implement_change_control (gated)

Example — label compliance review

> create_review(domain: "food_beverage", artifact_ref: "label:BAR-7", artifact_kind: "label", reviewer: "ra.lee")
> auto_screen(review_id: "REV-…", artifact_text: "Contains peanut and milk. All natural protein bar, supports immune health.")
  → 2 findings flagged: 21 CFR 101.4 (allergen labeling) · 16 CFR 260 (claims)
> complete_review(review_id: "REV-…")          → completed · verdict "compliant"

Example — change control with prior approval (CMC)

> open_change_control(title: "New API supplier", change_area: "manufacturing site", requested_by: "cmc")
> assess_reportability(change_control_id: "CC-…", reportability: "prior_approval", justification: "site change needs PAS")
> decide_change_control(change_control_id: "CC-…", approve: true)
> implement_change_control(change_control_id: "CC-…")
  → Error: prior-approval change requires an Approved linked submission
> create_submission(...) → add_section(complete:true) → submit(...) → record_determination(approved: true)
> link_submission(change_control_id: "CC-…", submission_id: "SUB-…")
> implement_change_control(change_control_id: "CC-…")   → implemented ✓

Installation

1. Build

git clone https://github.com/zavora-ai/mcp-regulatory
cd mcp-regulatory
cargo build --release

2. Add to your MCP client

Claude Desktop / Kiro / Cursor / Windsurf:

{
  "mcpServers": {
    "regulatory": {
      "command": "/path/to/mcp-regulatory"
    }
  }
}

3. Use it

> search_requirements(domain: "food_beverage", query: "allergen")
> search_changes(status: "action_required")

Governance & Data Handling

Gated regulatory-significant writes — review completion, submission filing, authority determination, and change-control decision/implementation require approval in production; reads and screening are read_only.
Filing is an external write — submit is classed external_write (it represents transmitting to a regulator).
Defensible records — reviews, submissions, and change controls carry immutable audit trails.
auto_screen is advisory — keyword screening is a triage aid, never a substitute for qualified regulatory review.
Integration scaffold — the in-memory store is for development; back it with your real RIM/regulatory system and bind actors to authenticated identities in production.

MCP Server Manifest

server_id = "mcp_regulatory"
display_name = "Regulatory Affairs"
version = "1.0.0"
domain = "compliance"
risk_level = "high"
writes_allowed = "gated"
transports = ["stdio"]

Contributors

|
_{James Karanja Maina} | |:---:|

License

Apache-2.0 — see LICENSE for details.

Part of the ADK-Rust Enterprise MCP server ecosystem.

Registry Compliance

This server implements the ADK MCP SDK contract:

HealthCheck — async health probe for registry monitoring
mcp-server.toml — manifest declaring tools, risk classes, and approval gates
Structured tracing — RUST_LOG env-filter for observability

MCP Servers