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life-sciences

30 skills across 4 jurisdictions.

Skills

United States flagUnited States · 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-…

CaseMark
United States flagUnited 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)…

CaseMark
United States flagUnited States · 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…

CaseMark
GENERAL · life-sciences

Conduct GxP Audit

Conduct a GxP audit of computerized systems and processes. Covers audit planning, opening meetings, evidence collection, finding classification (crit…

pjt222
GENERAL · life-sciences

Conduct GxP Audit

Conduct a GxP audit of computerized systems and processes. Covers audit planning, opening meetings, evidence collection, finding classification (crit…

pjt222
GENERAL · life-sciences

Design Compliance Architecture

Design a compliance architecture that maps applicable regulations to computerized systems. Covers system inventory, criticality classification (GxP-c…

pjt222
United States flagUnited States · 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 …

CaseMark
United States flagUnited States · 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…

CaseMark
United States flagUnited 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, …

diegosouzapw
United States flagUnited States · 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.

foolhardy45
United States flagUnited 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, …

diegosouzapw
United States flagUnited States · life-sciences

GMP Standard Operating Procedure

Drafts inspection-ready GMP standard operating procedures for regulated manufacturing. Covers document control, role accountability, process controls…

CaseMark
United States flagUnited States · 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…

CaseMark
United States flagUnited States · 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 …

CaseMark
United States flagUnited States · 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…

CaseMark
CROSS-JURISDICTION · life-sciences

KSB-D07-K0033: Policy Interpretation

Policy Interpretation: Guidance document analysis, regulatory precedent evaluation, interpretation consistency, implementat...

nexvigilant
European Union flagEuropean Union · 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…

borghei
United States flagUnited States · 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…

CaseMark
United States flagUnited States · life-sciences

Pharmaceutical Regulation Compliance Summary

Generates structured pharmaceutical regulatory compliance summaries covering FDA approval pathways, patent/IP intersections (Orange Book, Hatch-Waxma…

CaseMark
GENERAL · life-sciences

Prepare Inspection Readiness

Prepare an organisation for regulatory inspection by assessing readiness against agency-specific focus areas (FDA, EMA, MHRA). Covers warning letter …

pjt222
United States flagUnited States · 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 …

CaseMark
United States flagUnited States · 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…

CaseMark
European Union flagEuropean Union · 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 …

ovachiever
GENERAL · life-sciences

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。

pjt222

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.