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概要と使いどころ
Senior Regulatory Affairs Manager for HealthTech and MedTech. Use for regulatory strategy, FDA 510(k)/PMA/De Novo submissions, EU MDR CE marking, global market access, and regulatory intelligence.
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Senior Regulatory Affairs Manager for HealthTech and MedTech companies. Prepares FDA 510(k), De Novo, and PMA submission packages; analyzes regulatory pathways for new medical devices; drafts responses to FDA deficiency letters and Notified Body queries; develops CE marking technical documentation under EU MDR 2017/745; coordinates multi-market approval strategies across FDA, EU, Health Canada, PMDA, and NMPA; and maintains regulatory intelligence on evolving standards. Use when users need to plan or execute FDA submissions, navigate 510(k) or PMA approval processes, achieve CE marking, prepare pre-submission meeting materials, write regulatory strategy documents, respond to agency queries, or manage compliance documentation for medical device market access.
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Evaluates regulatory decision impact with approval probability, timeline analysis, and outcome scenario modeling for event-driven positions. Use when analyzing regulatory events, evaluating FDA/FCC/DOJ decisions, or modeling regulatory outcomes.
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Manages responses to regulatory complaints lodged with supervisory authorities under GDPR Article 77, covering internal escalation procedures, DPA response coordination, remediation tracking, and compliance documentation. Activate for regulatory complaint, supervisory authority complaint, Art. 77, DPA response, ICO complaint queries.
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Transforms Claude into a CFA-level financial analyst for specialty finance, regulatory compliance, and industry-specific analysis. Use when performing private credit pricing, insurance reserving, FP&A variance analysis, wealth planning, restructuring recovery analysis, real estate valuation, venture capital analysis, ESG assessment, regulatory capital analysis (Basel III), compliance reporting (MiFID II, GIPS), credit derivatives (CDS, CVA), convertible bond analysis, lease accounting (ASC 842/IFRS 16), pension funding/LDI, sovereign risk assessment, real option valuation, equity research (SOTP, target price), commodity spread trading, treasury operations, PPP infrastructure modelling, onshore fund structuring, offshore fund structuring, transfer pricing analysis (BEPS, Pillar Two), tax treaty optimisation, FATCA/CRS compliance, economic substance analysis, regulatory reporting (AIFMD, Form PF), AML/KYC compliance, crypto/DeFi analysis, municipal bond analysis, structured products, trade finance, fund of funds (J-curve, commitment pacing, manager selection, secondaries), bank analytics (NIM, CAMELS, CECL, deposit beta, loan book), carbon markets (credit pricing, ETS, CBAM, offsets, shadow carbon price), or private wealth (concentrated stock, philanthropic vehicles, wealth transfer, direct indexing, family governance) analysis is required. Pairs with corp-finance-mcp tools for computation.
日本語の概要は準備中です。原文の説明を表示しています。
Use the corp-finance-mcp server tools for specialty finance, regulatory, and compliance calculations. Invoke when performing private credit (unitranche, direct lending, syndication), insurance (loss reserving, premium pricing, Solvency II SCR), FP&A (variance analysis, break-even, working capital, rolling forecast), wealth management (retirement planning, tax-loss harvesting, estate planning), restructuring (recovery analysis, distressed debt), real assets (property valuation, project finance), venture capital (dilution, convertible instruments, fund returns), ESG (scoring, climate/carbon, green bonds, SLL), regulatory capital (Basel III, LCR/NSFR, ALM), compliance (MiFID II best execution, GIPS reporting), credit derivatives (CDS pricing, CVA/DVA), convertible bonds (binomial tree pricing, scenario analysis), lease accounting (ASC 842/IFRS 16, sale-leaseback), pension & LDI (funding analysis, liability-driven investing), sovereign risk (bond analysis, country risk), real options (binomial valuation, decision trees), equity research (SOTP, target price), commodity trading (spread analysis, storage economics), treasury management (cash management, hedge effectiveness), infrastructure finance (PPP models, concession valuation), crypto (token valuation, DeFi analysis), municipal bonds (pricing, credit analysis), structured products (notes, exotic), trade finance (LC, supply chain), fund structuring (US onshore, UK/EU, Cayman/BVI offshore, Luxembourg/Ireland), transfer pricing (BEPS/Pillar Two, intercompany pricing), tax treaty (treaty network optimization, holding structures), FATCA/CRS (reporting, entity classification), economic substance (multi-jurisdiction testing), regulatory reporting (AIFMD Annex IV, SEC Form PF, CFTC CPO-PQR), AML compliance (KYC risk scoring, sanctions screening), fund of funds (J-curve, commitment pacing, manager selection, secondaries pricing), bank analytics (NIM analysis, CAMELS rating, CECL provisioning, deposit beta, loan book), carbon markets (credit pricing, ETS compliance, CBAM, offset valuation, shadow carbon price), private wealth (concentrated stock, philanthropic vehicles, wealth transfer, direct indexing, family governance). All computation uses 128-bit decimal precision.
日本語の概要は準備中です。原文の説明を表示しています。
Coordinates fund regulatory requirements across SEC, AIFMD, and local jurisdiction registration, reporting, and compliance obligations. Use when managing fund compliance, navigating regulatory registration, or ensuring cross-border compliance.
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Evaluates regulatory differences across jurisdictions with comparative framework analysis and optimal domicile selection. Use when analyzing regulatory environments, comparing jurisdiction frameworks, or selecting fund domiciles.
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Evaluates regulated utility rate-setting with RAB methodology, allowed return analysis, and regulatory reset risk assessment. Use when analyzing regulatory frameworks, modeling rate cases, or evaluating allowed return mechanics.
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Discover and characterize regulatory elements (enhancers, promoters, silencers, insulators, super-enhancers) using ENCODE data and the cCRE catalog. Use when the user wants to find candidate regulatory elements, identify active enhancers in a tissue, map promoter states, classify chromatin states with ChromHMM, identify super-enhancers with ROSE, understand the functional validation hierarchy (CRISPR > MPRA > reporter), or characterize non-coding genomic regions. Covers the full workflow from ENCODE cCRE lookup through chromatin state segmentation to functional validation and enhancer-gene linkage. Use this skill for ANY regulatory element discovery, classification, or characterization task.
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Integrate multiple ENCODE data types (RNA-seq, ATAC-seq, Histone ChIP-seq, TF ChIP-seq) for a tissue/cell type to build a comprehensive regulatory landscape. Use when the user wants to answer "what are the enhancers, promoters, and regulatory elements active in my tissue, and which transcription factors control them?" by layering expression, chromatin accessibility, histone marks, and TF binding data. Follows the Mawla et al. 2023 framework for cross-assay integration of islet cell type-specific data. Handles chromatin state annotation (ChromHMM), enhancer-gene linkage, TF motif enrichment, and cell type-specific regulatory element identification. Use for ANY multi-omic analysis, enhancer discovery, regulatory network construction, or epigenomic characterization using ENCODE data.
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Use when setting up or auditing how compliance documentation is structured, collected, and preserved for regulatory audit in Salesforce FSC — covering KYC data collection workflows, AML screening integration setup, audit trail configuration, and regulatory reporting readiness. Triggers: KYC form setup, AML integration configuration, compliance data collection, audit trail setup, regulatory documentation workflow, Field Audit Trail configuration, Setup Audit Trail, Event Monitoring, Discovery Framework, FSC KYC objects, Identity Document setup, Party Identity Verification. NOT for security implementation, NOT for designing AML/KYC architecture (use architect/aml-kyc-process-architecture), NOT for configuring who can access deal or client data (use admin/compliant-data-sharing-setup).
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General Counsel advisory for startups: contract review (MSA, SaaS, NDA, DPA, employment), IP strategy, term sheet decoding, and regulatory landscape mapping. Use when reviewing any contract or term sheet, deciding when to engage outside counsel, defining IP strategy, evaluating regulatory exposure (HIPAA, GDPR, FDA, fintech), or when user mentions general counsel, GC, legal review, contract risk, term sheet, IP assignment, or regulatory exposure. NOT a substitute for licensed counsel — surfaces questions to bring to qualified attorneys.
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Check regulatory feeds now and report what's new since the last check, filtered by your materiality threshold. Use when the user says "check the feeds", "what's new", "regulatory update", when running from the scheduled agent, or when manually pasting a regulatory development for classification and diff.
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Analyzes documents and processes against FINRA, SEC, Federal Reserve, and CFPB regulatory frameworks. Identifies compliance gaps, classifies findings by severity, and recommends remediation. Use when performing compliance audits, regulatory reviews, gap analyses, or verifying policy adherence to financial regulations.
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Use when analyzing transcription factor (TF) regulatory networks using Dorothea database. Input gene list, identify regulating transcription factors, generate TF-Target network visualization. For: transcription factor enrichment analysis, gene regulatory network research.
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Build enhancer-driven gene regulatory networks (eGRNs) by integrating single-cell RNA-seq and ATAC-seq using SCENIC+, CellOracle base GRNs, Pando, FigR, DIRECT-NET, TRIPOD, and scMEGA. Covers the accessibility-defines-enhancers principle, peak-to-gene linking and its cell-composition confound, the paired-vs-unpaired decision, and TF-region-gene eRegulon triplets. Use when analyzing 10x multiome or paired/unpaired scRNA+scATAC to infer cis-regulatory GRNs. For RNA-only regulons see scenic-regulons; for in silico TF perturbation see perturbation-simulation.
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Infer gene regulatory networks from bulk or general expression data with mutual-information (ARACNe) and tree-ensemble (GENIE3, GRNBoost2) methods, and infer transcription-factor protein activity from regulons with VIPER and msVIPER. Covers the activity-not-edges paradigm, the undirected-association caveat, the DREAM5 wisdom-of-crowds and method-complementarity result, AUPRC-over-AUROC evaluation, and gold-standard incompleteness. Use when inferring a regulatory network from a bulk expression matrix, finding master regulators, or scoring TF activity from a signature. For single-cell motif-pruned regulons see scenic-regulons; for co-expression modules see coexpression-networks.
日本語の概要は準備中です。原文の説明を表示しています。
Annotates ChIP-seq peaks to genomic features, nearest genes, ENCODE candidate cis-regulatory elements (cCREs), and regulatory domains. Uses ChIPseeker (R), HOMER annotatePeaks.pl (CLI), pyranges (Python), GREAT/rGREAT (regulatory domain gene-set enrichment), ChIP-Enrich (locus-length-adjusted), ENCODE SCREEN cCRE classification (PLS/pELS/dELS/CA-CTCF/CA-H3K4me3), and ENCODE-rE2G for cell-type-specific enhancer-gene linking. Handles nearest-TSS vs host-gene ambiguity, promoter window definition, and feature priority. Use when assigning genomic context to peaks, linking enhancer peaks to target genes, classifying peaks against ENCODE cCRE registry, or running gene-set enrichment on peak-associated genes.
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Infer cis-regulatory connections (peak-to-peak co-accessibility) from scATAC-seq using Cicero, ArchR getCoAccessibility, or SCENIC+. Use when linking enhancer accessibility to promoter accessibility, identifying enhancer-gene pairs from chromatin alone (without paired RNA), running gene-regulatory inference combining ATAC + RNA, or comparing predicted regulatory contacts against Hi-C/Micro-C ground truth.
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Legal leadership advisor on legal strategy, risk, contract governance, and regulatory tracking. Use when defining a legal strategy, scoring legal risk, auditing the contract portfolio, or building a regulatory calendar.
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Use when an application or system — including one built quickly with AI coding agents — needs a security review with regulatory grounding: a STRIDE threat model, a LINDDUN privacy threat model, a dependency exposure screen against live CVE / CISA-KEV / EPSS data, or a selected, non-exhaustive screen of which EU security obligations (GDPR, NIS2, Cyber Resilience Act, AI Act) may apply and which need determination. Orchestrates the server-enforced threat-modeling workflows of the Ansvar Gateway MCP connector and grounds every regulatory statement in officially published text fetched at answer time — scope, role, and application-date limits stated, never a compliance verdict. Never simulates a workflow and never answers legal questions from model memory.
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Generates standalone interactive HTML "deal cards" that translate complex regulations into negotiation-ready reference tools, systematically distinguishing mandatory obligations from negotiable implementation choices. Use when the user needs an interactive regulatory guide for (1) contract negotiation support, (2) client education or internal training, (3) regulatory briefings for commercial stakeholders, or (4) structured comparison between required and flexible compliance paths. Primary focus on EU digital regulation (Data Act, AI Act, CRA, DORA, NIS2, GDPR) but the structural pattern transfers to any regulation where separating hard obligations from implementation choice is the point. Supports bilingual output where the jurisdiction calls for it.
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An end-to-end method for drafting and finalising a complex, multi-pillar regulated fintech agreement — from intake to signature. Authored from a senior fintech lawyer's manual: a licensed payment-services provider engaging a counterparty across agent cash-in/cash-out, QR payments, wallet e-payments, and a marketplace, each with its own regulatory profile. Runs five phases and fourteen steps: regulatory mapping (activity-to-licence matrix, grey-zone classification gates), architecture (framework-plus-sub-agreement structure, ring-fenced marketplace), the regulatory–commercial balance (what flexes vs what cannot), core drafting (authority, float mechanics, hard-coded regulator caps, liability — all tracking control), execution-blocker triage, and a pre-signature check closing open blockers as conditions precedent. It refuses to invent licence-specific values or draft a representation as true without executed evidence. Use it to structure, draft, negotiate, or review any regulated payments contract.
日本語の概要は準備中です。原文の説明を表示しています。