Regulatory Affairs Specialist AI Skill - Adalgisa
Get a product through regulatory approval and keep it compliant: choose the right pathway, map the dossier to what it actually requires, and pre-empt deficiencies.
Claude skill package instant downloadadalgisa-regulatory-affairs-specialist.skill
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Example
You: What's the right regulatory pathway for this device, and what does our 510(k) dossier need to include?
AI: Adalgisa returns a classification determination and pathway recommendation with cited regulation, a dossier table of contents mapped against required data elements wit...
This is not an app. It's an expert you add to your own AI.
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// the file itself
The first lines of the file your AI will read, exactly as delivered. Nothing rewritten for the page.
You are Adalgisa, a Senior Regulatory Affairs Specialist for pharma and medical devices who determines the pathway before assembling a dossier, whether 510(k), PMA, NDA or MAA. You have been activated to cite the regulation behind every requirement.
// what's inside
Pharma and medical device teams navigating FDA/EMA approval, who need a defensible pathway strategy and a submission built to survive review.
// two ways to get it
$12/mo cancel anytime, or $99 a year
$19 one payment
Already on Library or Both? This one is included, no need to buy the file.
// ask your assistant
Go to kissmyskills.com/pages/connector and set up the "Regulatory Affairs Specialist AI Skill - Adalgisa" skill (handle: adalgisa-regulatory-affairs-specialist) for me
Paste it into Claude, ChatGPT, Claude Code, Cursor or Codex. Your AI walks you through connecting KissMySkills (about 3 minutes, 7-day free trial) and loads the skill. What your AI will read →
Drop 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.
Adalgisa 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.
What you get
EU MDR Technical File & ISO 14971 Risk File
Adalgisa includes a step-by-step method for the two documents a notified body reads hardest: the MDR technical documentation and the risk management file.
How to install
Download 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.
After checkout, the download link lands in your inbox. Save the .skill file: Claude takes it as it is.
Any AI chat you already use: Claude, ChatGPT, Gemini, Grok, Copilot or another.
Claude: turn on code execution in Settings → Capabilities, then Customize → Skills → + → Create skill → Upload a skill and pick the .skill file. ChatGPT, Gemini and others: open the .skill file like a .zip archive and paste SKILL.md into custom instructions or Project instructions.
Your AI is now configured as a specialist. Ask it anything inside its domain.
No technical knowledge required.
Get a product through regulatory approval and keep it compliant: choose the right pathway, map the dossier to what it actually requires, and pre-empt deficiencies. Load it once into Claude Projects and you get a configured Regulatory Affairs Specialist (Pharma/Medical Device) without re-explaining context at the start of every session. Verify every clinical, regulatory, research, or academic recommendation against current professional standards, institutional policy, and a licensed or credentialed professional before acting on it - this skill accelerates the work, it does not replace professional judgment or licensure.
Yes, as a drafting tool. Adalgisa maps the technical documentation to MDR Annex II and III with a gap table, sets up the GSPR checklist, and structures the risk management file on the clauses of ISO 14971:2019 with a hazard table and traceability checks. Acceptability criteria are left for your company to set, and every output is a draft for your regulatory and quality sign-off; article numbers and standard editions should be confirmed against current official sources.
Download the .skill package (it contains SKILL.md), then, in Claude, turn on code execution in Settings → Capabilities and add it under Customize → Skills → + → Create skill → Upload a skill (in ChatGPT, Gemini or another AI, open it as a .zip and paste SKILL.md into Project instructions or custom instructions), add your own context and start your first session. Works with Claude, ChatGPT, or any AI chat that accepts system prompts.
Works with Claude (recommended), ChatGPT, Gemini, Perplexity and Copilot, and any AI chat that accepts system prompts. Claude Projects gives the best results.
This one and 2,500+ others, inside Claude, ChatGPT, Claude Code, Codex or Cursor. Cancel anytime.
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