Drafts attorney-supervised, state-compliant U.S. Advance Health Care Directives that appoint health care agents, resolve the HIPAA access gap, and record clinically usable treatment preferences. Enforces state-law verification for execution formalities,…
Drafts SEC Form D notices of exempt offering and Form D/A amendments for operating companies and pooled investment funds, mapped one-to-one to the form's 16 items. Runs a source-review gate over the matter inventory, builds an evidence-to-field worksheet for…
Drafts litigation-ready U.S. pre-suit demand letters that function as settlement instruments and defensible future exhibits. Enforces element-driven narratives, verified authority, damages methodology, and ethics guardrails. Use this skill when the user…
Drafts the nonclinical sections of an FDA IND in Common Technical Document format from primary study reports, namely the Module 2.4 Nonclinical Overview and the Module 2.6 Written and Tabulated Summaries for pharmacology, pharmacokinetics and toxicology.…
Drafts a sponsor's Investigator's Brochure for an IND or clinical trial of a drug or biologic under 21 CFR 312.23(a)(5), 312.55 and ICH E6, from nonclinical study reports or Module 2 summaries, CMC documents, protocols and any human data. Covers the summary,…
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,…
Audits the complete in-scope medical-record universe in a litigation matter and produces an attorney-facing, Bates-cited analysis of treatment gaps, missing records or providers, baseline coverage, material billing or production mismatches, and complaint…
Citation format and verification protocol for legal documents that draw on Bates-stamped source records. Defines the bracket citation format, multi-source citation rules, quotation handling, the verification pass that runs before output, and the [UNVERIFIED]…