Life Sciences & Pharma — United States
U.S. FDA-regulated life sciences — 510(k) and IND/NDA submissions, device registration and listing, clinical-trial and investigator agreements and informed consent, GMP SOPs, quality agreements, adverse-event reporting, promotional-materials review, and pharma regulatory summaries.
Skills
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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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
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
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
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
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
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
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
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
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
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
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
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
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…