Skill Packages

Browse ready-made AI workflow skills for document elaboration, review, and structuring.

CSA NI 51-102 — Material Change Report

Draft and validate the Material Change Report for Canadian reporting issuers under NI 51-102 Part 7 and Form 51-102F3. Ensures description of material change, date, and impact for prompt SEDAR+ filing.

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    CSA NI 51-102 — MD&A

    Draft and validate Management's Discussion & Analysis for Canadian reporting issuers under NI 51-102 Part 5 and Form 51-102F1. Ensures required themes and period-over-period discussion for SEDAR+ filing.

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      Data Privacy — AIPD (CNIL Standard)

      Conduct a Privacy Impact Assessment (AIPD) under the CNIL standard for France (RGPD). Three-step methodology: Context, Principles, Risks. Validates retention periods against CNIL 'droit à l'oubli' (right to erasure).

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        Data Processing Agreement (DPA) — SCC & sub-processor sync

        Draft the legal annex for DPAs governing controller–processor data transfers under GDPR and CCPA. Inserts the correct Standard Contractual Clauses by data importer country and validates sub-processor list against the privacy portal.

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          Design Dossier Elaborator

          Guided elaboration of design dossier, technical file, or device master record sections for medical devices: risk summary, essential principles (GSPR), labelling, and traceability to risk file and standards per MDR Annex II/III and FDA design control.

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            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.

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              Doc Co-Authoring

              Guide users through a structured workflow for collaboratively writing documents, proposals, specs, and decision docs. Uses a three-stage process: context gathering, iterative refinement, and reader testing.

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                DORA Capability Assessment

                Draft and maintain the DORA capability assessment document: technical and cultural capabilities that drive delivery performance, with evidence and maturity per capability, linked to the four key metrics.

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                  DORA Metrics Narrative

                  Draft and maintain the DORA four key metrics narrative: deployment frequency, lead time for changes, MTTR, and change fail rate. Covers current state, targets, trends, and measurement approach.

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                    Dossiê CBPF — GMP Document Factory

                    Preparação para inspeções de certificação de plantas fabris (CBPF). Gera POPs e registros de treinamento; valida o Plano Mestre de Validação quanto à qualificação de equipamentos térmicos e utilidades. Mercado: medicamentos e saneantes. Regulação: ANVISA, RDC 658/2022.

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                      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).

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                        DPC Cross-Border Data Processing (Lead SSA)

                        Draft Article 30 Records of Processing Activities for US firms using Ireland as Lead Supervisory Authority. Covers main establishment justification (GDPR Art. 4(16), EDPB criteria) and validation so the Irish DPC remains the competent authority.

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