Search Skills
918 skills found
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 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, …
United States
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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.
United States
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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, …
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
USPTO Office Actions und TESS/TSDR-Recherche
USPTO Office Actions beantworten und TESS/TSDR-Datenbankrecherche: Prüfungsbescheid des USPTO nach Markenanmeldung erhalten. Normen: 15 U.S.C. § 1052…
United States
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ip
USPTO Database
公式記録の検索、PatentSearch クエリ、TSDR チェック、譲渡データ、および再現可能な IP 調査ログのための USPTO 特許・商標データワークフロー。
United States
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ip
USPTO Database
Access USPTO APIs for patent/trademark searches, examination history (PEDS), assignments, citations, office actions, TSDR, for IP analysis and prior …
United States
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ip
USPTO Database
Access USPTO APIs for patent/trademark searches, examination history (PEDS), assignments, citations, office actions, TSDR, for IP analysis and prior …
United States
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ip
USPTO-Anmeldung und Lanham Act
USPTO-Markenanmeldung nach Lanham Act durchführen: Modehaus will Markenschutz in den USA. Normen: 15 U.S.C. § 1051 ff. (Lanham Act), 37 C.F.R. § 2.21…
United States
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ip
USPTO Database
Access USPTO APIs for patent/trademark searches, examination history (PEDS), assignments, citations, office actions, TSDR, for IP analysis and prior …
United States
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ip
US Trade Dress und Secondary Meaning
US Trade Dress Protection für Produktaufmachung und Produktgestaltung: Luxusmarke will Gesamterscheinungsbild oder Produktform in den USA schützen. N…
United States
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ip
US Counterfeit Enforcement und CBP Recordation
US-Counterfeit-Enforcement und CBP-Recordation: Luxusmarke will gefaelschte Ware in den USA stoppen. Normen: 18 U.S.C. § 2320 (Trademark Counterfeiti…
United States
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ip
TTAB — Trademark Trial and Appeal Board
TTAB-Opposition und Cancellation in den USA führen: aeltere Marke kollidiert mit US-Anmeldung oder eingetragener Marke. Normen: 37 C.F.R. § 2.101 ff.…
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. …