# 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.

Jurisdiction: `us` · Practice: `life-sciences` · Skill language varies per skill (see each `SKILL.md`).

## Skills (16)

| Skill | Practice |
|---|---|
| [`510k-premarket-notification`](skills/510k-premarket-notification/) | `life-sciences` |
| [`adverse-event-reporting-policy`](skills/adverse-event-reporting-policy/) | `life-sciences` |
| [`clinical-trial-agreement`](skills/clinical-trial-agreement/) | `life-sciences` |
| [`clinical-trial-investigator-agreement`](skills/clinical-trial-investigator-agreement/) | `life-sciences` |
| [`fda-device-registration`](skills/fda-device-registration/) | `life-sciences` |
| [`fda-medtech-compliance-auditor`](skills/fda-medtech-compliance-auditor/) | `life-sciences` |
| [`fda-medtech-compliance-auditor-foolhardy45`](skills/fda-medtech-compliance-auditor-foolhardy45/) | `life-sciences` |
| [`fda-medtech-compliance-auditor-v2`](skills/fda-medtech-compliance-auditor-v2/) | `life-sciences` |
| [`gmp-sop`](skills/gmp-sop/) | `life-sciences` |
| [`ind-application`](skills/ind-application/) | `life-sciences` |
| [`informed-consent-form-clinical-trial`](skills/informed-consent-form-clinical-trial/) | `life-sciences` |
| [`investigator-agreement`](skills/investigator-agreement/) | `life-sciences` |
| [`nda-drug-application`](skills/nda-drug-application/) | `life-sciences` |
| [`pharma-reg-summary`](skills/pharma-reg-summary/) | `life-sciences` |
| [`promo-materials-review-policy`](skills/promo-materials-review-policy/) | `life-sciences` |
| [`quality-agreement`](skills/quality-agreement/) | `life-sciences` |

## Cold-start context

See [`CLAUDE.md`](CLAUDE.md) — scope, forums, sources of law, citation discipline, and when this plugin does NOT apply.

## Provenance & license

Skills relocated here during a practice-area re-classification. See each `SKILL.md` `author` / `author_url` for provenance and `license` for terms.

## Disclaimer

These skills produce informational drafts and analyses, not legal advice. Verify against current law before use.
