Regulatory & Compliance — United States
Regulatory & Compliance skills for United States (imported from open sources; see each skill's author_url for provenance).
Skills
United States
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regulatory
FDA 510(k) Premarket Notification
Drafts FDA 510(k) Premarket Notification submissions demonstrating substantial equivalence under 21 CFR Part 807. Supports Traditional, Special, and …
United States
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regulatory
Adverse Event Reporting Policy
Drafts an Adverse Event Reporting Policy compliant with 21 CFR 312.32 (IND safety reporting), 21 CFR 314.80 (postmarketing), and ICH E2A, with multi-…
United States
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regulatory
Client Advisory Summary
Drafts U.S. regulatory client advisory summaries translating legal developments into actionable risk and compliance guidance. Use when a client needs…
United States
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regulatory
AML Compliance Program
Drafts board-ready Anti-Money Laundering compliance programs for U.S. financial institutions under BSA/FinCEN requirements. Covers CIP, CDD, EDD, SAR…
United States
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regulatory
Annual Report for State Charity Bureau
Generates a cross-referenced U.S. nonprofit annual filing package for state charity-bureau registration. Produces Full Compliance Package, Form-Field…
United States
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regulatory
Legal Audit Summary
Produces structured U.S. legal audit summaries that distill compliance findings into executive-ready risk prioritization and remediation plans, cover…
United States
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regulatory
US EAR, ITAR und Extraterritorialität
US-Exportkontrolle EAR ITAR und OFAC für Unternehmen mit US-Bezug im Aussenhandel. Anwendungsfall Produkt enthaelt US-Komponenten oder unterliegt US-…
United States
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Aviation Law Summary
Generates structured U.S. aviation-law summaries by synthesizing FAA, DOT, and TSA rules, treaties, and precedent into actionable legal analysis. Use…
United States
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AWA Compliance Audit (USDA/APHIS)
Produces an enforcement-aware Animal Welfare Act compliance audit for USDA/APHIS-regulated facilities. Maps Form 7002 inspection citations to verifie…
United States
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regulatory
Legislative Bill Summary
Produces neutral, section-pinned U.S. legislative bill summaries translating statutory language into plain terms with identifying data, provisions, f…
United States
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regulatory
BSA/AML Risk Assessment
Drafts a BSA/AML Risk Assessment for U.S. financial institutions per FinCEN, FFIEC, and OCC standards. Evaluates inherent risks (customer, product, g…
United States
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regulatory
C-TPAT Security Profile
Drafts a U.S. C-TPAT Security Profile for CBP submission covering physical, personnel, procedural, conveyance, and IT security domains. Use when prep…
United States
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regulatory
CBP Binding Ruling Request (19 CFR Part 177)
Drafts U.S. Customs and Border Protection binding ruling requests under 19 CFR Part 177 for tariff classification, valuation, origin, and marking det…
United States
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regulatory
USMCA/NAFTA Certificate of Origin
Drafts USMCA/NAFTA Certificates of Origin for preferential tariff treatment on US-Mexico-Canada goods. Verifies origin criteria, HS classifications, …
United States
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regulatory
Charitable Solicitation Registration
Prepares jurisdiction-specific charitable solicitation registration packages for U.S. nonprofits. Covers multi-state nexus analysis, exemption eligib…
United States
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regulatory
Annual Report for State Charity Bureau
Drafts filing-ready Annual Reports for State Charity Bureaus with certified financials, governance disclosures, and required attachments. Extracts or…
United States
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regulatory
State Charity Filing Threshold Research
Researches state-specific charitable solicitation filing requirements keyed to gross revenue, producing a citation-backed state-by-state compliance m…
United States
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regulatory
Client Advisory Summary
Produces client-ready U.S. regulatory advisory summaries translating legal developments into actionable impacts with effective-date tracking and Blue…
United States
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regulatory
CMMC 2.0 Compliance Skill
Expert CMMC 2.0 (Cybersecurity Maturity Model Certification) advisor for US defense contractors and subcontractors in the Defense Industrial Base (DI…
United States
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regulatory
Compliance Auditor
Federal acquisition compliance auditor for the active Theseus workspace, backed by live FAR/DFARS text via the vendored `ecfr` MCP. USE WHEN the user…
United States
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regulatory
Compliance Checker
Check affiliate content for FTC compliance and platform rules. Triggers on: "check my content for compliance", "FTC disclosure check", "is this legal…
United States
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Congressional Testimony Preparation
Prepares witnesses for U.S. congressional hearings with committee member profiling, predicted question matrices, mock Q&A rounds, and procedural guid…
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regulatory
Corporate Compliance Checklist
Drafts a U.S. corporate compliance program checklist anchored in DOJ ECCP, Federal Sentencing Guidelines Chapter 8, and SEC enforcement priorities. C…
United States
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regulatory
C-TPAT Security Profile
Drafts a submission-ready C-TPAT Security Profile from verified company records for U.S. CBP enrollment, recertification, or validation prep. Use whe…
United States
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regulatory
Customs Power of Attorney
Drafts a U.S. Customs Power of Attorney authorizing a licensed customs broker to transact customs business on behalf of an importer or exporter under…
United States
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regulatory
CBP Form 19 — Protest of Customs Decision
Drafts CBP Form 19 protests under 19 U.S.C. § 1514 and 19 C.F.R. Part 174 challenging tariff classification, valuation, origin, and trade preference …
United States
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regulatory
DD Form 254 — Contract Security Classification Specification
Drafts DD Form 254 Contract Security Classification Specifications for classified government contracts. Use when preparing security classification sp…
United States
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regulatory
Pages: Disclosure
When the user wants to create, optimize, or audit an affiliate, sponsor, or paid partnership disclosure page. Also use when the user mentions "disclo…
United States
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regulatory
Export Administration Regulations (EAR) Compliance Skill
Export Administration Regulations (EAR, 15 CFR Parts 730-774) compliance advisor — ECCN classification across all 10 CCL categories and 5 product gro…
United States
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regulatory
Export Compliance Program (ECP) Manual
Drafts an audit-ready Export Compliance Program manual covering EAR, ITAR, and OFAC requirements. Use when creating or updating an export compliance …
United States
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regulatory
Energy Regulation Summary
Generates structured summaries of U.S. energy sector regulations and landmark cases with compliance-focused analysis. Use when summarizing FERC order…
United States
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Exporter of Record (EOR) Agreement
Drafts a U.S.-compliant Exporter of Record (EOR) Agreement appointing a third party as USPPI for international export transactions. Allocates complia…
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ExChek Deemed Export / Foreign National Review
Walk through 15 CFR 734.2(b) to determine if a release of technology or source code to a foreign national is a deemed export. Covers nationality, tec…
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regulatory
FCPA Compliance Policy
Drafts an implementable Foreign Corrupt Practices Act (FCPA) Compliance Policy for U.S.-jurisdictional corporations with international operations. Co…
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regulatory
FDA Establishment Registration & Device Listing
Drafts FDA Establishment Registration and Device Listing documents compliant with 21 CFR Part 807. Structures filings with establishment details, own…
United States
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regulatory
FDA MedTech Compliance Auditor
FDA MedTech Compliance Auditor workflow skill. Use this skill when the user needs Expert AI auditor for Medical Device (SaMD) compliance, IEC 62304, …
United States
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regulatory
FDA MedTech Compliance Auditor
Expert AI auditor for Medical Device (SaMD) compliance, IEC 62304, and 21 CFR Part 820. Reviews DHFs, technical files, and software validation.
United States
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regulatory
FDA MedTech Compliance Auditor
FDA MedTech Compliance Auditor workflow skill. Use this skill when the user needs Expert AI auditor for Medical Device (SaMD) compliance, IEC 62304, …
United States
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regulatory
Input: poam_tsv = "fedramp_poam_2025.tsv"
Validates FedRAMP Plan of Action and Milestones (POAM) files for structural integrity, naming conventions, deduplication, and cross-sheet consistency
United States
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regulatory
FERC Market-Based Rate Tariff
Drafts eTariff-ready FERC Market-Based Rate Tariffs for wholesale electric energy, capacity, and ancillary services sales. Use when preparing MBR tar…
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regulatory
Fintech Regulatory Summaries
Generates structured regulatory summaries for fintech compliance covering crypto, payments, lending, mobile banking, and money transmission. Covers C…
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regulatory
FDA Food Facility Registration
Drafts an FDA Food Facility Registration under FSMA and 21 CFR Part 1, Subpart H (21 U.S.C. 350d). Covers facility identity, food product categories,…
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regulatory
Professional Fundraiser Contract Compliance Check
Audits professional solicitor, fundraising counsel, and commercial co-venturer contracts for state charitable solicitation compliance. Classifies rel…
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regulatory
Gambling Law Regulatory Summary
Produces jurisdiction-specific U.S. gambling law regulatory summaries covering legal status, licensing, taxes, enforcement, and pending reforms. Use …
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regulatory
Gas Gathering Agreement
Drafts a Gas Gathering Agreement for receipt, compression, dehydration, and transportation of natural gas from wellhead to delivery point. Enforces F…
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regulatory
GMP Standard Operating Procedure
Drafts inspection-ready GMP standard operating procedures for regulated manufacturing. Covers document control, role accountability, process controls…
United States
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GSA Schedule Contract
Drafts FAR/GSAR-compliant GSA Schedule (MAS/FSS) contracts with clause matrices, SIN scope, pricing/PRC/EPA mechanics, IFF reporting, TAA, Section 50…
United States
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regulatory
HACCP Plan
Drafts U.S. HACCP plans for food production under FDA or USDA regimes. Triggers on requests involving HACCP plans, food safety plans, hazard analysis…
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regulatory
Historic Preservation Law Summary
Produces a structured U.S. historic preservation law summary covering federal, state, and local authorities, key cases, takings analysis, designation…
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Import Compliance Manual
Drafts a U.S. import compliance manual demonstrating reasonable care under 19 U.S.C. § 1484. Covers HTS classification, customs valuation (19 U.S.C. …
United States
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regulatory
IND Application
Drafts FDA Investigational New Drug (IND) applications under 21 CFR Part 312, including Form 1571, Investigator's Brochure, clinical protocols, CMC s…
United States
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regulatory
Interconnection Agreement
Drafts U.S. telecommunications Interconnection Agreements (ICAs) under 47 U.S.C. §§ 251-252 and FCC Part 51, covering POIs, traffic classification, r…
United States
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regulatory
ITAR Compliance Skill
Expert ITAR compliance advisor for US defense contractors, exporters, and manufacturers. Use this skill for any question about 22 CFR Parts 120-130, …
United States
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regulatory
ITAR Technology Control Plan (TCP)
Drafts ITAR Technology Control Plans (TCPs) for managing USML defense articles and technical data under 22 CFR Parts 120-130. Covers DDTC registratio…
United States
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regulatory
ITAR Technology Control Plan
Drafts an ITAR Technology Control Plan (TCP) for U.S. export control compliance under 22 CFR 120-130. Use when a user needs to create or update a TCP…
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regulatory
FDA Labeling Compliance Review
Conducts FDA labeling compliance reviews for drugs, foods, dietary supplements, and medical devices. Analyzes principal display panels and informatio…
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regulatory
New Drug Application (NDA)
Drafts an eCTD-compliant New Drug Application (NDA) for FDA submission under 21 CFR Part 314. Compiles clinical trial data, CMC documentation, noncli…
United States
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regulatory
NYDFS Information Security Program (23 NYCRR 500)
Drafts a comprehensive Information Security Program compliant with NYDFS Cybersecurity Regulation (23 NYCRR 500). Covers CISO designation, risk asses…
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regulatory
OCI Mitigation Plan
Drafts FAR 9.5-compliant Organizational Conflict of Interest mitigation plans for federal government contractors. Analyzes unequal access, impaired o…
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regulatory
Past Performance Questionnaire
Drafts a Past Performance Questionnaire for evaluating legal service providers or contractors in government contract contexts. Trigger when the user …
United States
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Pharmaceutical Regulation Compliance Summary
Generates structured pharmaceutical regulatory compliance summaries covering FDA approval pathways, patent/IP intersections (Orange Book, Hatch-Waxma…
United States
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regulatory
Promotional Materials Review Policy
Drafts an internal Promotional Materials Review Policy for life sciences and pharmaceutical companies under FDA oversight. Covers promotional review …
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regulatory
Notice of Intent to Protest Award
Drafts a formal Notice of Intent to Protest Award for federal contracts under FAR 33.103, 33.104, and 4 C.F.R. Part 21. Use when a client receives an…
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regulatory
Quality Agreement for Contract Manufacturing
Drafts Quality Agreements for pharmaceutical contract manufacturing. Assigns quality roles between product owners and CMOs under FDA cGMP (21 CFR 210…
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regulatory
Request for Equitable Adjustment (REA)
Drafts a Request for Equitable Adjustment (REA) for U.S. federal government contracts under FAR provisions. Enforces element-driven cost/schedule nar…
United States
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regulatory
Recall Plan and Procedure
Drafts FDA product recall plans compliant with 21 CFR Part 7, covering Recall Committee governance, health hazard evaluation, recall classification, …
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Regulatory Practice
Navigates regulatory compliance, government relations, and administrative law across financial services, healthcare, environmental, FDA, privacy, ene…
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regulatory
Regulatory Analysis
Analyzes documents and processes against FINRA, SEC, Federal Reserve, and CFPB regulatory frameworks. Identifies compliance gaps, classifies findings…
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regulatory
Thesis
Track legislation, regulatory actions, and legal developments affecting prediction markets, crypto, and AI agents — triaged by stage × impact for dec…
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regulatory
Regulatory Submission Summary
Produces structured summaries of regulatory submission packages (FDA NDAs, 510(k)s, BLAs, ANDAs, environmental permits, rate filings) for government …
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regulatory
RFP Response
Drafts evaluation-ready U.S. federal RFP responses across all standard proposal volumes (cover letter, technical, cost/price, reps and certs). Enforc…
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regulatory
SAM.gov Representations and Certifications
Drafts Representations and Certifications documents for SAM.gov federal contractor registration. Use when registering entities in SAM.gov, updating a…
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regulatory
SAR Filing
Drafts FinCEN Suspicious Activity Reports (Form 111) for BSA/AML regulatory filing. Compiles subject identification, transaction timelines, red-flag …
United States
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regulatory
Shipper's Letter of Instruction (SLI)
Drafts a U.S.-focused Shipper's Letter of Instruction (SLI) authorizing a freight forwarder, capturing EEI/AES filing intent, and documenting export-…
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Space Law Case Summary
Generates structured summaries of space law cases involving satellite deployment, space debris, orbital conflicts, launch licensing, and internationa…
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State Charity Bureau Annual Report
Drafts U.S. state charity bureau annual report packages for nonprofit charitable solicitation compliance. Use when preparing a state charitable solic…
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Small Business Subcontracting Plan
Drafts a FAR 52.219-9-compliant Small Business Subcontracting Plan for federal prime contractors. Sets percentage goals for SB, SDB, WOSB, HUBZone, V…
United States
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Telecommunications Law Summary
Generates executive-level summaries of recent US telecommunications law developments covering spectrum rights, network access, privacy, infrastructur…
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International Trade Law Summary
Produces structured U.S.-focused international trade law summaries covering tariffs, customs, export controls, sanctions, trade remedies, and trade a…
United States
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regulatory
Escheatment and Unclaimed Property Policy
Drafts an enterprise Escheatment and Unclaimed Property Policy covering property identification, dormancy matrices, due diligence notices, NAUPA-form…
United States
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regulatory
US Export Controls Expert
US Export Controls expert covering ITAR and EAR. Provides comprehensive guidance on defense articles (USML), dual-use commercial items (CCL), jurisdi…
