Search Skills
883 skills found
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
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
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
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
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
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
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
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
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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
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
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
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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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ip
Work for Hire Agreement
Drafts a U.S. Work for Hire Agreement under 17 U.S.C. §§ 101 and 201(b) with fallback IP assignment, creator warranties, and indemnification. Trigger…
United States
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ip
Trademark License Agreement
Drafts a U.S. Trademark License Agreement governing a licensor's grant of rights to a licensee for authorized use of registered or common law marks. …
United States
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ip
Trademark Coexistence Agreement
Drafts U.S. trademark coexistence agreements defining permitted use boundaries, differentiation requirements, and confusion-prevention protocols for …
United States
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ip
Trademark Clearance Search Report
Generates a trademark clearance search report evaluating mark availability and registrability across federal (USPTO TESS), state, common law, and int…
United States
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ip
Trademark Cease-and-Desist Letter
Drafts U.S. trademark cease-and-desist letters asserting ownership, documenting infringement, and issuing cure demands with deadlines. Trigger when t…
United States
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ip
Trademark Cease-and-Desist Letter
Drafts a U.S. trademark cease-and-desist letter for pre-litigation enforcement. Converts case facts into a demand letter that establishes standing, d…
United States
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ip
Technology Tutorial for Court
Drafts a neutral, educational slide-deck technology tutorial for courts in patent litigation. Covers the technical problem, prior art, invention oper…
United States
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ip
Quality Control Provisions (Trademark License Exhibit)
Drafts Quality Control Provisions as an exhibit to a Trademark License Agreement, covering quality standards, inspection rights, sample approval, non…
United States
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ip
Proprietary Information and Inventions Agreement (PIIA)
Drafts U.S. Proprietary Information and Inventions Agreements (PIIA) for employee or consultant onboarding. Use when drafting a PIIA, inventions assi…
United States
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ip
Patent Infringement Case Summary
Generates structured summaries of patent infringement cases covering parties, patents-at-issue, infringement theories, claim construction, damages, a…
United States
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ip
Patent Infringement Complaint
Drafts a federal patent infringement complaint for U.S. District Court satisfying FRCP Rules 8, 10, 11 and Twombly/Iqbal plausibility. Covers direct …
United States
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ip
Patent Infringement Analysis
Generates a structured patent infringement analysis mapping claims to accused product features via claim charts. Covers Phillips claim construction, …