{"product_id":"adalgisa-regulatory-affairs-specialist","title":"Adalgisa — Regulatory Affairs Specialist (Pharma\/Medical Device) AI Skill","description":"\u003cdiv style=\"font-family: 'DM Sans', sans-serif; color: #1A1A18; max-width: 680px;\"\u003e\n  \u003cp style=\"font-size: 16px; font-weight: 600; line-height: 1.5; margin: 0 0 8px 0;\"\u003eDrop Adalgisa into Claude and get a Senior Regulatory Affairs Specialist who gets pharma and medical device products through FDA, EMA, and equivalent bodies, and keeps them compliant afterward.\u003c\/p\u003e\n  \u003cp style=\"font-size: 13px; color: #555550; line-height: 1.7; margin: 0 0 28px 0;\"\u003eAdalgisa covers the full regulatory affairs cycle: regulatory pathway and submission strategy determined from actual risk classification, dossier assembly (510(k), PMA, IND\/NDA\/BLA, MAA) mapped against what the specific pathway requires, pre-submission deficiency-risk review, labeling compliance checked against approved data, and post-market surveillance filings tracked against their real regulatory deadlines.\u003c\/p\u003e\n  \u003cdiv style=\"background: #E7F8F5; border-radius: 12px; padding: 24px 28px; margin-bottom: 24px;\"\u003e\n    \u003cp style=\"font-size: 10px; font-weight: 600; color: #1B7E6A; letter-spacing: 0.08em; text-transform: uppercase; margin: 0 0 16px 0;\"\u003eWhat you get\u003c\/p\u003e\n    \u003cul style=\"margin: 0; padding: 0; list-style: none;\"\u003e\n\u003cli style=\"font-size: 13px; padding: 7px 0; border-bottom: 1px solid rgba(27,126,106,0.14); display: flex; gap: 10px;\"\u003e\n\u003cspan style=\"color:#1B7E6A; font-weight:600;\"\u003e→\u003c\/span\u003e\u003cspan\u003eRegulatory pathway determined from actual risk classification, never the sponsor's preferred timeline\u003c\/span\u003e\n\u003c\/li\u003e\n\u003cli style=\"font-size: 13px; padding: 7px 0; border-bottom: 1px solid rgba(27,126,106,0.14); display: flex; gap: 10px;\"\u003e\n\u003cspan style=\"color:#1B7E6A; font-weight:600;\"\u003e→\u003c\/span\u003e\u003cspan\u003eDossier table of contents mapped to the specific pathway's required data elements\u003c\/span\u003e\n\u003c\/li\u003e\n\u003cli style=\"font-size: 13px; padding: 7px 0; border-bottom: 1px solid rgba(27,126,106,0.14); display: flex; gap: 10px;\"\u003e\n\u003cspan style=\"color:#1B7E6A; font-weight:600;\"\u003e→\u003c\/span\u003e\u003cspan\u003eDraft dossiers reviewed for internal consistency and likely deficiency questions pre-submission\u003c\/span\u003e\n\u003c\/li\u003e\n\u003cli style=\"font-size: 13px; padding: 7px 0;  display: flex; gap: 10px;\"\u003e\n\u003cspan style=\"color:#1B7E6A; font-weight:600;\"\u003e→\u003c\/span\u003e\u003cspan\u003eEvery requirement cited to a specific regulation, guidance document, or standard\u003c\/span\u003e\n\u003c\/li\u003e\n    \u003c\/ul\u003e\n  \u003c\/div\u003e\n  \u003cdiv style=\"display:flex; align-items:center; gap:20px; background:#FFFFFF; border:1px solid #E8E6E0; border-radius:8px; padding:14px 20px; margin-bottom:24px;\"\u003e\n    \u003cspan style=\"font-size:11px; color:#888780; font-family:monospace;\"\u003e📄 adalgisa-regulatory-affairs-specialist.skill\u003c\/span\u003e\n    \u003cspan style=\"font-size:11px; color:#888780;\"\u003eUnder 2 min install\u003c\/span\u003e\n    \u003cspan style=\"font-size:11px; color:#888780;\"\u003eWorks with Claude, ChatGPT \u0026amp; any AI chat\u003c\/span\u003e\n  \u003c\/div\u003e\n  \u003cdiv style=\"border-left:3px solid #1B7E6A; padding-left:16px;\"\u003e\n    \u003cp style=\"font-size:10px; font-weight:600; color:#1B7E6A; letter-spacing:0.08em; text-transform:uppercase; margin:0 0 6px 0;\"\u003eHow to install\u003c\/p\u003e\n    \u003cp style=\"font-size:12px; color:#555550; line-height:1.7; margin:0;\"\u003eDownload the .skill package → open Claude → paste SKILL.md into your Project Instructions or system prompt → describe your requirement → Adalgisa builds the answer. Includes a full worked example so you see exactly what you get.\u003c\/p\u003e\n  \u003c\/div\u003e\n\u003c\/div\u003e","brand":"KissMySkills","offers":[{"title":"Default Title","offer_id":58370422669576,"sku":null,"price":14.99,"currency_code":"USD","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/1036\/1444\/7880\/files\/fn42-adalgisa-regulatory-affairs-specialist-nf.png?v=1785953937","url":"https:\/\/kissmyskills.com\/ro\/products\/adalgisa-regulatory-affairs-specialist","provider":"KissMySkills","version":"1.0","type":"link"}