Life sciences legal-AI skills in 🇺🇸 United States

16 legal AI skills for life sciences in United States.

Adverse Event Reporting Policy

Apache-2.0United StatesLife sciences

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-jurisdictional overlays (EMA, PMDA, Health Canada). Covers seriousness/causality frameworks, expedited reporting timelines, roles, documentation standards, training mandates, and QA mechanisms. Use when drafting or updating an adverse event reporting policy, pharmacovigilance policy, AE/SAE reporting SOP, or safety reporting framework for a pharmaceutical company, CRO, biotech, or clinical research institution.

Clinical Trial Agreement

Apache-2.0United StatesLife sciences

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). Use when drafting or negotiating CTAs, sponsor research agreements, or protocol-specific contracts for investigational drugs, devices, or biologics.

Clinical Trial Investigator Agreement

Apache-2.0United StatesLife sciences

Drafts U.S. clinical trial Investigator Agreements between sponsors/CROs and principal investigators or institutions for FDA-regulated drug, biologic, or device studies. Enforces 21 CFR Parts 50, 56, 312/812, ICH GCP E6(R2), HIPAA, IRB requirements, FMV/AKS payment compliance, data integrity, publication rights, IP ownership, indemnity, and audit access. Use when drafting investigator agreements, PI agreements, clinical trial site agreements, or sponsor-PI contracts; trigger keywords: investigator agreement, clinical trial agreement, PI agreement, FDA, IND, IDE, IRB, GCP, clinical research agreement, site agreement.

FDA 510(k) Premarket Notification

Apache-2.0United StatesLife sciences

Drafts FDA 510(k) Premarket Notification submissions demonstrating substantial equivalence under 21 CFR Part 807. Supports Traditional, Special, and Abbreviated pathways. Use when preparing Class II medical device regulatory filings, substantial equivalence analyses, or FDA premarket submissions.

FDA Establishment Registration & Device Listing

Apache-2.0United StatesLife sciences

Drafts FDA Establishment Registration and Device Listing documents compliant with 21 CFR Part 807. Structures filings with establishment details, owner/operator information, device inventories, compliance certifications, and signature blocks mirroring FDA Form 2830. Triggers on initial registrations, annual renewals, listing updates, or foreign establishment filings requiring US agent designations.

FDA MedTech Compliance Auditor

MITUnited StatesLife sciences

FDA MedTech Compliance Auditor workflow skill. Use this skill when the user needs Expert AI auditor for Medical Device (SaMD) compliance, IEC 62304, and 21 CFR Part 820. Reviews DHFs, technical files, and software validation and the operator should preserve the upstream workflow, copied support files, and provenance before merging or handing off.

FDA MedTech Compliance Auditor

MITUnited StatesLife sciences

Expert AI auditor for Medical Device (SaMD) compliance, IEC 62304, and 21 CFR Part 820. Reviews DHFs, technical files, and software validation.

FDA MedTech Compliance Auditor

MITUnited StatesLife sciences

FDA MedTech Compliance Auditor workflow skill. Use this skill when the user needs Expert AI auditor for Medical Device (SaMD) compliance, IEC 62304, and 21 CFR Part 820. Reviews DHFs, technical files, and software validation and the operator should preserve the upstream workflow, copied support files, and provenance before merging or handing off.

GMP Standard Operating Procedure

Apache-2.0United StatesLife sciences

Drafts inspection-ready GMP standard operating procedures for regulated manufacturing. Covers document control, role accountability, process controls, deviation/CAPA handling, and records management aligned to FDA CGMP (21 CFR 210/211), Part 11, ICH Q7/Q9/Q10, WHO GMP, PIC/S, and EU GMP. Use when creating or overhauling a GMP SOP, preparing for audits or inspections, or building compliance-ready procedures. Trigger: GMP, SOP, CGMP, 21 CFR 210, 21 CFR 211, Part 11, ICH Q7, ICH Q9, ICH Q10, WHO GMP, PIC/S, EU GMP.

IND Application

Apache-2.0United StatesLife sciences

Drafts FDA Investigational New Drug (IND) applications under 21 CFR Part 312, including Form 1571, Investigator's Brochure, clinical protocols, CMC sections, and nonclinical data packages. Use when preparing IND submissions, pre-IND packages, IND amendments, or clinical trial authorization documents.

Informed Consent Form — Clinical Trial

Apache-2.0United StatesLife sciences

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 or revising consent documents for Phase I–IV trials, IND studies, or other FDA-regulated protocols requiring IRB submission.

Investigator Agreement

Apache-2.0United StatesLife sciences

Drafts Investigator Agreements for FDA-regulated clinical trials between sponsors and principal investigators. Covers 21 CFR Parts 50, 56, 312/812, ICH GCP E6(R2), IRB governance, data integrity, IP, indemnification, financial terms, and termination. Use when preparing clinical trial investigator agreements, site agreements, PI agreements, or sponsor-investigator contracts for drug, biologic, or device studies.

New Drug Application (NDA)

Apache-2.0United StatesLife sciences

Drafts an eCTD-compliant New Drug Application (NDA) for FDA submission under 21 CFR Part 314. Compiles clinical trial data, CMC documentation, nonclinical studies, pharmacokinetics, integrated safety analyses, and proposed labeling into five-module eCTD structure. Use when preparing an NDA, FDA drug approval submission, pharmaceutical regulatory filing, or eCTD assembly for a new molecular entity.

Pharmaceutical Regulation Compliance Summary

Apache-2.0United StatesLife sciences

Generates structured pharmaceutical regulatory compliance summaries covering FDA approval pathways, patent/IP intersections (Orange Book, Hatch-Waxman), and marketing restrictions (off-label, DTC, Anti-Kickback). Use when preparing FDA compliance overviews, submission readiness assessments, or promotional compliance reviews.

Promotional Materials Review Policy

Apache-2.0United StatesLife sciences

Drafts an internal Promotional Materials Review Policy for life sciences and pharmaceutical companies under FDA oversight. Covers promotional review committee structure, fair balance requirements, substantiation standards, off-label prohibitions, recordkeeping, training, and auditing. Use when creating FDA promotional compliance governance frameworks, pharma advertising policies, or promotional review committee charters.

Quality Agreement for Contract Manufacturing

Apache-2.0United StatesLife sciences

Drafts Quality Agreements for pharmaceutical contract manufacturing. Assigns quality roles between product owners and CMOs under FDA cGMP (21 CFR 210/211), ICH Q7, and related guidance. Use when a user needs a quality agreement, CMO quality terms, or cGMP compliance agreement for contract manufacturing.

Life sciences legal-AI skills in United States · ThomasMore AI