# Skills tagged "Regulatory" 48 skills with this tag. URL: https://rakenne.app/skill-tags/regulatory/index.md - [10-K Risk Factors (Item 1A)](https://rakenne.app/skills/sec-10k-risk-factors/index.md) — 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, … - [BCAR Building Control](https://rakenne.app/skills/bcar-building-control/index.md) — 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 … - [Biotech Dossier Expert — Terapias Avançadas (ANVISA)](https://rakenne.app/skills/biotech-dossier-expert/index.md) — 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 … - [Building Safety Golden Thread Auditor](https://rakenne.app/skills/golden-thread-auditor/index.md) — 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 … - [CAA Drone Safety Cases (UAS)](https://rakenne.app/skills/caa-uas-osc/index.md) — 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), … - [CASA Drone Operating Safety Case (OSC)](https://rakenne.app/skills/casa-drone-osc/index.md) — 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 … - [Clinical Trial Protocol (ICH E6 R3)](https://rakenne.app/skills/clinical-trial-protocol/index.md) — 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, … - [DiGA Fast-Track](https://rakenne.app/skills/diga-fast-track/index.md) — 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 … - [Dossier AMM France — HAS / ANSM](https://rakenne.app/skills/maa-dossier-has-ansm/index.md) — 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 … - [DUERP — Document Unique (France)](https://rakenne.app/skills/duerp-document-unique/index.md) — 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 … - [eCTD Cross-Module Verifier](https://rakenne.app/skills/ectd-cross-module-verifier/index.md) — 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, … - [EMA CTD Module 1 — Regional Administrative & Prescribing Information](https://rakenne.app/skills/ema-ctd-module1-application/index.md) — 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)](https://rakenne.app/skills/environmental-referrals-epbc/index.md) — 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 … - [EU AI Act — High-Risk AI System Technical Documentation](https://rakenne.app/skills/eu-ai-act-high-risk-technical-doc/index.md) — 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 … - [FCA Consumer Duty — Fair Value Assessment](https://rakenne.app/skills/fca-consumer-duty-fva/index.md) — 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 … - [FDA Submission Wizard](https://rakenne.app/skills/fda-submission-wizard/index.md) — 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) … - [Fire Protection Concepts (BauO)](https://rakenne.app/skills/fire-protection-bauo/index.md) — Erstellt Brandschutzkonzepte fuer Baugenehmigungen nach den deutschen Landesbauordnungen (LBOs) und der Musterbauordnung (MBO). Berechnet Rettungsweglaengen und Rauchabschnitte nach Gebaeuedeklasse … - [Gestão de Contratos Agrícolas (Proagro)](https://rakenne.app/skills/crop-loss-justifier/index.md) — 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 … - [Health Canada & MDSAP](https://rakenne.app/skills/health-canada-mdsap/index.md) — 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 … - [Incident Decision Tree Builder](https://rakenne.app/skills/incident-decision-tree-builder/index.md) — 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 … - [ISO 27001 Legal & Regulatory Requirements Register](https://rakenne.app/skills/iso27001-legal-requirements-register/index.md) — 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](https://rakenne.app/skills/marisk-risk-elaborator/index.md) — Erstellt und prueft Risikomanagement-Handbuecher fuer Finanzinstitute in Deutschland gemaess MaRisk (BaFin). Unterstuetzt die vollstaendige Ausarbeitung aller MaRisk-Module (AT, BT, BTR), … - [MD&A — Driver-Based Drafting (Item 303)](https://rakenne.app/skills/sec-mda/index.md) — 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 … - [MDevSPICE Regulatory Readiness Narrative](https://rakenne.app/skills/mdevspice-regulatory-readiness-narrative/index.md) — 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)](https://rakenne.app/skills/memoire-technique-public-procurement/index.md) — 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 … - [Modern Slavery Statements (AU)](https://rakenne.app/skills/modern-slavery-statement-au/index.md) — 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 … - [Periodic Benefit-Risk Evaluation Report (PBRER / ICH E2C(R2))](https://rakenne.app/skills/ich-pbrer-pharmacovigilance/index.md) — 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 … - [Pesquisa de Preços em Compras Públicas](https://rakenne.app/skills/bid-price-rationalizer/index.md) — 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 … - [Planos de Manejo Florestal Sustentável (PMFS)](https://rakenne.app/skills/forest-yield-optimizer/index.md) — 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 … - [PPSPS — Plan Particulier de Sécurité et de Protection de la Santé (France)](https://rakenne.app/skills/ppsps-safety-plan/index.md) — Elaboration of the PPSPS for French construction sites under OPPBTP/CSPS. Ensures structure, secours, évacuation hospitalière, and site-specific emergency contacts. Validation via … - [QMS CAPA Tracker](https://rakenne.app/skills/qms-capa-tracker/index.md) — 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 … - [Railway RAMS Lifecycle Validator](https://rakenne.app/skills/rams-lifecycle-validator/index.md) — 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 … - [Rapport de Gestion — Tribunal de Commerce (France)](https://rakenne.app/skills/rapport-de-gestion/index.md) — 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 … - [RAS — Relatório Ambiental Simplificado](https://rakenne.app/skills/env-licensing-ras/index.md) — 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 … - [RCA — Relatório de Controle Ambiental](https://rakenne.app/skills/env-licensing-rca/index.md) — 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 … - [RCA/PCA — Medidas Mitigadoras e Monitoramento](https://rakenne.app/skills/rca-pca-mitigation/index.md) — 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. … - [Relatórios Prudenciais CMN/BCB](https://rakenne.app/skills/prudential-reporting-bacen/index.md) — 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 … - [Sandbox Compliance Expert](https://rakenne.app/skills/sandbox-compliance-expert/index.md) — 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 … - [SEC DEF 14A (Proxy Statement)](https://rakenne.app/skills/sec-proxy-def14a/index.md) — 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 … - [SEC Form 10-Q (Quarterly Report)](https://rakenne.app/skills/sec-form-10q/index.md) — 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 … - [SEC Form 8-K (Current Report)](https://rakenne.app/skills/sec-form-8k/index.md) — 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)](https://rakenne.app/skills/sfcr-solvency-ii/index.md) — 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 … - [SRA Accounts Rules — Accountant's Report & Compliance](https://rakenne.app/skills/sra-accounts-rules/index.md) — 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, … - [UK Modern Slavery Statements](https://rakenne.app/skills/uk-modern-slavery-statements/index.md) — 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, … - [UK Public Procurement (Procurement Act 2023)](https://rakenne.app/skills/uk-procurement-act-2023/index.md) — 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 … - [Validador de Folletos Informativos (CNMV)](https://rakenne.app/skills/prospectus-validator/index.md) — 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 … - [VgV Procurement Note](https://rakenne.app/skills/vgv-procurement-note/index.md) — Erstellt und validiert den Vergabevermerk (Procurement Note) nach VgV § 8 / UVgO § 6 fuer oeffentliche Vergabeverfahren, einschliesslich nachpruefungsfester Zuschlagsbegruendung und … - [VOB Contract Enforcer](https://rakenne.app/skills/vob-contract-enforcer/index.md) — Validiert Bauausschreibungen und Bauvertraege gegen die VOB (Vergabe- und Vertragsordnung) und DIN-Normen, einschliesslich Klauselpruefung, Leistungsverzeichnis-Struktur und Konformitaets-Checklisten. --- Back to [All Tags](https://rakenne.app/skill-tags/) | [Skill Library](https://rakenne.app/skills/)