life-sciences
30 skills across 4 jurisdictions.
European Union
2
European Union
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life-sciences
MDR 2017/745 Specialist
EU MDR 2017/745 compliance specialist for medical device classification, technical documentation, clinical evidence, and post-market surveillance. Co…
European Union
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life-sciences
Senior MDR 2017/745 Specialist and Consultant
EU MDR 2017/745 regulation specialist and consultant for medical device requirement management. Provides comprehensive MDR compliance expertise, gap …
United States
16
United States
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life-sciences
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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life-sciences
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
·
life-sciences
Clinical Trial Agreement
Drafts U.S. clinical trial agreements governing sponsor–site–investigator relationships under FDA rules (21 CFR Parts 50, 56, 312) and ICH-GCP E6(R2)…
United States
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life-sciences
Clinical Trial Investigator Agreement
Drafts U.S. clinical trial Investigator Agreements between sponsors/CROs and principal investigators or institutions for FDA-regulated drug, biologic…
United States
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life-sciences
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
·
life-sciences
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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life-sciences
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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life-sciences
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
·
life-sciences
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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life-sciences
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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life-sciences
Informed Consent Form — Clinical Trial
Drafts an IRB-ready Informed Consent Form (ICF) for FDA-regulated clinical trials compliant with 21 CFR 50.25, 50.27, and ICH-GCP. Use when drafting …
United States
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life-sciences
Investigator Agreement
Drafts Investigator Agreements for FDA-regulated clinical trials between sponsors and principal investigators. Covers 21 CFR Parts 50, 56, 312/812, I…
United States
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life-sciences
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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life-sciences
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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life-sciences
Promotional Materials Review Policy
Drafts an internal Promotional Materials Review Policy for life sciences and pharmaceutical companies under FDA oversight. Covers promotional review …
United States
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life-sciences
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…
CROSS-JURISDICTION 1
KSB-D07-K0033: Policy Interpretation
Policy Interpretation: Guidance document analysis, regulatory precedent evaluation, interpretation consistency, implementat...
GENERAL 11
Conduct GxP Audit
Conduct a GxP audit of computerized systems and processes. Covers audit planning, opening meetings, evidence collection, finding classification (crit…
行 GxP 稽核
Conduct a GxP audit of computerized systems and processes. Covers audit planning, opening meetings, evidence collection, finding classification (crit…
Conduct GxP Audit
Conduct a GxP audit of computerized systems and processes. Covers audit planning, opening meetings, evidence collection, finding classification (crit…
Design Compliance Architecture
Design a compliance architecture that maps applicable regulations to computerized systems. Covers system inventory, criticality classification (GxP-c…
設合規架構
Design a compliance architecture that maps applicable regulations to computerized systems. Covers system inventory, criticality classification (GxP-c…
監測資料完整性
Design and operate a data integrity monitoring programme based on ALCOA+ principles. Covers detective controls, audit trail review schedules, anomaly…
Prepare Inspection Readiness
Prepare an organisation for regulatory inspection by assessing readiness against agency-specific focus areas (FDA, EMA, MHRA). Covers warning letter …
備檢查就緒
備組織受監管檢查：對機構特定焦點區（FDA, EMA, MHRA）評備度。含警告信 與 483 主題析、模擬檢查協、文件包備、檢查事務、應對模板。 監管檢查已宣或預期、定期自評、上檢後已施新系、或重大審計發現或致監管注時用之。
備檢準備度
Prepare an organisation for regulatory inspection by assessing readiness against agency-specific focus areas (FDA, EMA, MHRA). Covers warning letter …
資廠商
資 GxP 相關軟體或服務之廠商或供。含廠險分、評問卷設、案頭與現場審法、 質協評、SLA 審、續監節奏定。 GxP 關鍵系統擇新廠、為合規數納雲供、行定期重資、審發現需重評、 或 EU Annex 11 或 ICH Q10 要供資時用之。
書驗文
Write IQ/OQ/PQ validation documentation for computerized systems in regulated environments. Covers protocols, reports, test scripts, deviation handli…