Regulatory
Skill packages tagged with “Regulatory”
10-K Risk Factors (Item 1A)
Draft and validate the Risk Factors section of a Form 10-K under Reg S-K Item 105: organize by materiality, write company-specific narratives, add a two-page summary when the section exceeds 15 pages, and validate structure and compliance.
BCAR Building Control
Draft and validate the Certificate of Compliance on Completion and the Assigned Certifier's inspection plan under Ireland's Building Control (Amendment) Regulations (BCAR). Ensures the inspection plan covers all mandatory Ancillary Certificates (Form Annexes) from sub-contractors for structural elements, with validation via ancillary_cert_sync.
Biotech Dossier Expert — Terapias Avançadas (ANVISA)
Elaboração do dossiê técnico para registro de produtos de terapias avançadas (células, tecidos, terapias gênicas). Organiza documentação de CQ, esterilidade e dados clínicos conforme RDC 338/2020 e Agenda Regulatória 2026. Inclui validação de integridade aséptica.
Building Safety Golden Thread Auditor
Draft and audit Safety Case Reports for high-rise residential buildings under the UK Building Safety Act 2022. Validates external wall system specifications against the combustible materials ban (SI 2018/1230), checks for required test evidence (BS 8414 / BR 135), and ensures the digital golden thread meets BSR requirements.
CAA Drone Safety Cases (UAS)
Draft and validate the Operating Safety Case (OSC) for complex UAS operations under the UK CAA. Covers the three-volume structure per CAP 722A (Operations Manual, Technical Manual, Risk Assessment), ground and air risk, and integration with risk evaluation and airspace checks.
CASA Drone Operating Safety Case (OSC)
Draft and validate the Operating Safety Case (OSC) for complex drone operations in Australia under CASA and CASR Part 101. SORA-aligned risk assessment (GRC, ARC, SAIL) and no-fly zone check against Australian PRD airspace. Logistics and agriculture.
Clinical Trial Protocol (ICH E6 R3)
Draft clinical trial protocols compliant with ICH E6(R3) and ICH E8(R1). Covers study design, objectives, endpoints, eligibility criteria, estimand framework (ICH E9(R1)), statistical analysis plan, safety monitoring, IDMC, RBQMS, and regulatory submission requirements (FDA IND / EU CTR 536/2014 via CTIS) for all study phases and therapeutic areas.
DiGA Fast-Track
Prepare and validate Fast-Track applications for listing Digital Health Applications (DiGA) in the BfArM directory per DiGAV. Cross-checks clinical study protocols against claimed Positive Versorgungseffekte and audits technical documentation for ISiK interoperability standards compliance.
Dossier AMM France — HAS / ANSM
Préparer et vérifier les dossiers d'Autorisation de mise sur le marché (AMM/MAA) pour le marché français. Contexte HAS et ANSM, structure CTD, cohérence des données d'essais cliniques (avec maa_dossier_check).
DUERP — Document Unique (France)
Creation and annual update of the French single document for occupational risk assessment (DUERP), per Code du Travail R4121-1. Covers work units, risk inventory, 10 pénibilité factors mapping, and update frequency check after significant changes.
eCTD Cross-Module Verifier
Verify consistency and data integrity of eCTD pharmaceutical dossiers. Cross-checks Module 2 (Summaries) against Module 5 (Clinical Study Reports) to ensure study references, p-values, N-counts, endpoints, and safety data are aligned before regulatory submission to FDA, EMA, or PMDA.
EMA CTD Module 1 — Regional Administrative & Prescribing Information
Draft and validate EU Module 1 of the Common Technical Document for MAA: application form, SmPC, PIL, labelling, and environmental risk assessment per EU requirements.
Environmental Referrals (EPBC Act)
Draft Referral of Proposed Action for developments affecting matters of national environmental significance (MNES) under the EPBC Act. Covers Ramsar wetlands, threatened species, mitigation and offsets, and DCCEEW submission. Australia; land development and infrastructure.
EU AI Act — High-Risk AI System Technical Documentation
Draft and validate the technical documentation required for high-risk AI systems under the EU AI Act (Regulation 2024/1689) Annex IV. Covers system description, risk management (Art. 9), data governance (Art. 10), human oversight (Art. 14), accuracy/robustness metrics, and conformity assessment preparation.
FCA Consumer Duty — Fair Value Assessment
Elaborate and validate Fair Value Assessments (FVAs) for UK retail banking and insurance products under the FCA Consumer Duty. Covers PRIN 2A, FG22/5, required FVA sections, price-vs-value and vulnerable-customer consideration. Works alongside disclosure (plain English) and customer-journey (sludge) checks.
FDA Submission Wizard
Draft and validate FDA medical device submissions. Supports 510(k) Premarket Notifications (eSTAR format) with predicate comparison and substantial equivalence arguments, and PMA (Premarket Approval) dossiers with clinical and non-clinical data sections.
Fire Protection Concepts (BauO)
Erstellt Brandschutzkonzepte fuer Baugenehmigungen nach den deutschen Landesbauordnungen (LBOs) und der Musterbauordnung (MBO). Berechnet Rettungsweglaengen und Rauchabschnitte nach Gebaeuedeklasse und Bundesland, validiert Hochhaus-Konzepte gegen die Muster-Hochhausrichtlinie (M-HHR) 2026.
Gestão de Contratos Agrícolas (Proagro)
Elaboração de laudos de comprovação de perdas para acionamento de seguro rural. Estrutura a justificativa técnica com base em eventos climáticos e zoneamento ZARC (MAPA), com validação de coordenadas x calendário de plantio.
Health Canada & MDSAP
Align QMS documentation to MDSAP and Health Canada expectations. Guides users to map procedures and records to MDSAP/ISO 13485, prepare for audits, and use the mdsap_audit_aligner skill when available.
Incident Decision Tree Builder
Draft scenario-specific incident response playbooks (NIST CSF RS.RP) with a clear Decision Matrix for isolate vs. monitor and logic gates for Containment, Eradication, and Recovery. Inserts or validates mandatory regulatory reporting windows (e.g. GDPR 72h, SEC 4 days) in the playbook timeline.
ISO 27001 Legal & Regulatory Requirements Register
Identify, document, and track all legal, statutory, regulatory, and contractual requirements relevant to information security per ISO 27001 Control A.5.31.
MaRisk Risikomanagement-Handbuch
Erstellt und prueft Risikomanagement-Handbuecher fuer Finanzinstitute in Deutschland gemaess MaRisk (BaFin). Unterstuetzt die vollstaendige Ausarbeitung aller MaRisk-Module (AT, BT, BTR), Konformitaetspruefungen und Identifikation von Dokumentationsluecken.
MD&A — Driver-Based Drafting (Item 303)
Draft Management's Discussion and Analysis for 10-K or 10-Q with a driver-based structure: results of operations, liquidity and capital resources, known trends and uncertainties, and critical accounting estimates. Includes validation for required subsections, causation language, and non-GAAP reconciliation.
MDevSPICE Regulatory Readiness Narrative
Draft a regulatory readiness narrative for FDA (21 CFR 820), EU MDR, and IEC 62304; document evidence and alignment for audit or submission.
Mémoire Technique — Marchés Publics (France)
Structural elaboration of the technical proposal for French public tenders. Aligns the mémoire technique with the RC (Règlement de la Consultation) critères de jugement and ensures the Clause Sociale et Environnementale (RSE) is detailed with measurable KPIs. Validation via check_rse_scoring.
Modern Slavery Statements (AU)
Annual drafting of Modern Slavery Statements for the Australian regime under the Modern Slavery Act 2018 (Cth). Covers the seven mandatory criteria (s16), approval by the principal governing body, and submission to the ABF Online Register. For entities with consolidated revenue ≥ A$100m.
Periodic Benefit-Risk Evaluation Report (PBRER / ICH E2C(R2))
Draft and validate the Periodic Benefit-Risk Evaluation Report per ICH E2C(R2). Integrates cumulative safety and efficacy data for an authorised medicinal product, producing a benefit-risk evaluation for regulatory submission to EMA, FDA (PADER), and other authorities.
Pesquisa de Preços em Compras Públicas
Elaboração do Mapa de Preços e justificativa do valor estimado para licitações. Consolida cotações de fontes oficiais (Painel de Preços, fornecedores, atas de RP), identifica preços inexequíveis ou excessivos e calcula o valor estimado conforme IN SEGES/ME 65/2021.
Planos de Manejo Florestal Sustentável (PMFS)
Documentação técnica para exploração de florestas nativas: ciclo de corte, intensidade por hectare e auditoria de espécies CITES/ameaçadas no inventário. Regulado por IN MMA 05/2006 e órgãos estaduais (IBAMA).
PPSPS — Plan Particulier de Sécurité et de Protection de la Santé (France)
Elaboration of the PPSPS for French construction sites under OPPBTP/CSPS. Ensures structure, secours, évacuation hospitalière, and site-specific emergency contacts. Validation via emergency_contact_sync. Document co-activité risks explicitly where applicable.
QMS CAPA Tracker
Draft and validate CAPA (Corrective and Preventive Action) reports for medical device quality management systems. Standardizes root cause analysis using 5 Whys or Fishbone (Ishikawa) methods, enforces Effectiveness Check completeness, and validates CAPA structure against ISO 13485 and FDA 21 CFR Part 820 requirements.
Railway RAMS Lifecycle Validator
Elaborate and validate a Safety Case for railway signaling systems per EN 50126. Covers the full V-model lifecycle (Concept to Decommissioning), SIL 1–4 allocation with failure rate consistency checks, hazard analysis, risk assessment, and CENELEC standard compliance for EU railway projects.
Rapport de Gestion — Tribunal de Commerce (France)
Draft the annual management report for the French Commercial Court under Code de Commerce. Covers mandatory content and the LME-mandated table of payment delays (fournisseurs/clients). Validation via payment_delay_validator. Complements commercial-code-auditor for mandatory mentions.
RAS — Relatório Ambiental Simplificado
Elabora e revisa Relatórios Ambientais Simplificados (RAS) para licenciamento ambiental no Brasil, com foco em empreendimentos de pequeno porte ou baixo impacto. Subsidia Licença Ambiental Simplificada (LAS) ou Licença Prévia (LP), conforme CONAMA 279/2001 e normas estaduais.
RCA — Relatório de Controle Ambiental
Apoia a elaboração e revisão de Relatórios de Controle Ambiental (RCA) para licenciamento ambiental no Brasil, com foco em regularização de empreendimentos e renovação de licenças, incluindo diagnóstico ambiental, plano de controle e validação de completude.
RCA/PCA — Medidas Mitigadoras e Monitoramento
Redação técnica de medidas mitigadoras para Relatórios de Controle Ambiental (RCA) e Planos de Controle Ambiental (PCA), com vínculo impacto–monitoramento e verificação de efluentes contra CONAMA 430. Foco em mineração e transformação (médio impacto); órgãos CETESB, INEA, SEMAD.
Relatórios Prudenciais CMN/BCB
Apoia a elaboracao e revisao de divulgacoes prudenciais no Brasil com foco em CMN/BCB (Pilar 3, ICAAP e riscos sociais, ambientais e climaticos), incluindo checklist de conformidade e validacao de completude.
Sandbox Compliance Expert
Elaboração de propostas para sandbox regulatório e contratos de inovação (CVM, BCB, SUSEP). Define critérios de saída segura e limites de operação; valida proteção ao consumidor e responsabilidade civil conforme LC 182/2021.
SEC DEF 14A (Proxy Statement)
Draft and validate annual meeting proxy statements for U.S. domestic issuers: meeting and voting mechanics, proposals, director nominees, beneficial ownership, executive compensation (scaled for SRC/EGC), audit matters, and Part III 10-K incorporation mapping.
SEC Form 10-Q (Quarterly Report)
Generate and validate quarterly Form 10-Q narrative sections and checklists, with delta-focused updates, Risk Factors (material changes only), Legal Proceedings, Controls and Procedures, and consistency checks.
SEC Form 8-K (Current Report)
Draft and validate SEC Form 8-K filings for any reportable corporate event, with item mapping, compliance checks, and standard legal language.
SFCR Solvency II (Pillar 3)
Supports preparation and review of the Solvency and Financial Condition Report (SFCR) for EU insurance and reinsurance undertakings under Solvency II Pillar 3, including QRT consistency checks and MCR/SCR ratio validation.
SRA Accounts Rules — Accountant's Report & Compliance
Draft and validate Accountant's Reports and internal compliance manuals for UK law firms under the SRA Accounts Rules 2019. Validates client/office money segregation, residual client balance policies, reconciliation, breach reporting, and all major SRA Accounts Rules requirements.
UK Modern Slavery Statements
Annual drafting of transparency statements for the UK government registry under the Modern Slavery Act 2015 (s54). Covers the six recommended areas—organisation structure and supply chains, policies, due diligence, risk assessment and management, KPIs, training—and registry requirements (board approval, director sign-off).
UK Public Procurement (Procurement Act 2023)
Draft and validate Selection Questionnaires and Tender Responses under the UK Procurement Act 2023. Covers exclusion grounds (Schedules 6 & 7), debarment list checks, Social Value evaluation per PPN 06/20 with TOMs framework, and SQ completeness validation.
Validador de Folletos Informativos (CNMV)
Ayuda a elaborar y revisar folletos informativos de fondos de inversión en España conforme a la normativa CNMV, MiFID II y la Ley del Mercado de Valores, con checklist de conformidad y validación de completitud.
VgV Procurement Note
Erstellt und validiert den Vergabevermerk (Procurement Note) nach VgV § 8 / UVgO § 6 fuer oeffentliche Vergabeverfahren, einschliesslich nachpruefungsfester Zuschlagsbegruendung und XVergabe-Pflichtfeldvalidierung.
VOB Contract Enforcer
Validiert Bauausschreibungen und Bauvertraege gegen die VOB (Vergabe- und Vertragsordnung) und DIN-Normen, einschliesslich Klauselpruefung, Leistungsverzeichnis-Struktur und Konformitaets-Checklisten.