life-sciences
30 skills across 4 jurisdictions.
European Union (2)
United States (16)Skills
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 …
書驗文
Write IQ/OQ/PQ validation documentation for computerized systems in regulated environments. Covers protocols, reports, test scripts, deviation handli…
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…
行 GxP 稽核
Conduct a GxP audit of computerized systems and processes. Covers audit planning, opening meetings, evidence collection, finding classification (crit…
設合規架構
Design a compliance architecture that maps applicable regulations to computerized systems. Covers system inventory, criticality classification (GxP-c…
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。
life-sciences legal skills by jurisdiction
Regulatory approval pathways, clinical trial agreements, IP licensing, pharmacovigilance obligations, and product liability exposure all converge in life sciences work — often simultaneously and across multiple regulators. The legal skills covering life sciences in the ThomasMore catalog address that complexity directly, whether the matter involves FDA submissions, EMA procedures, national competent authorities, or the interplay between patent term extensions and market exclusivity regimes. Each skill is agent-ready, built to draft, review, or analyse a specific task in this sector, and reachable over MCP or as a direct download into your existing workflow.
From biotech licensing negotiations and orphan drug designations to clinical site contracts and post-market surveillance reporting, these skills reflect the regulatory and transactional demands that life sciences counsel actually face. Authors maintain them as guidance from health authorities and IP offices evolves, keeping the capabilities current rather than static. The ThomasMore catalog lets you filter by jurisdiction, license, or author, so whether you work in the US, EU, or any other market, you can narrow to the skills most relevant to the regulatory environment your client operates in.