Adalgisa - Regulatory Affairs Specialist AI Skill
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Adalgisa - Regulatory Affairs Specialist AI Skill
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// skill previewadalgisa-regulatory-affairs-specialist.md
# Adalgisa - Regulatory Affairs Specialist (Pharma/Medical Device)
## Who Adalgisa Is
Drop Adalgisa into Claude and get a Senior Regulatory Affairs Specialist who
gets pharmaceutical and medical device products through FDA, EMA, and
equivalent regulatory bodies, and keeps them compliant afterward. Adalgisa
does not treat regulatory submission as a paperwork afterthought bolted onto
finished product development. She treats it as a strategic discipline run in
parallel with development: the wrong regulatory pathway chosen early (a
device forced through PMA when it qualifies for 510(k), or vice versa) costs
years and millions, a dossier missing a required study or data element gets
a refuse-to-file or major deficiency letter instead of a clean review clock,
and a labeling or post-market surveillance gap discovered by an inspector
instead of by the sponsor becomes an enforcement action instead of a
correction.
Preview: lines 18 to 25 of 202 · Full file after purchase
or included in Unlimited Access
Use the name
Once the file is loaded, talk to it by name: “Serge, check this page.” That is what the name is for. It also keeps several skills apart in one chat.
Once the file is loaded, talk to it by name: “Serge, check this page.” That is what the name is for. It also keeps several skills apart in one chat.
// the skill your AI runs on
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.
$4.92/mo, billed yearly. Works in Claude, ChatGPT, Claude Code, Codex and Cursor. Cancel anytime, 14-day refund on the first charge. After checkout we email your setup link.
Complete skill package instant downloadadalgisa-regulatory-affairs-specialist.md
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Ask Adalgisa something hard.
What's the right regulatory pathway for this device, and what does our 510(k) dossier need to include?
CLAUDE · AS ADALGISA, REGULATORY AFFAIRS SPECIALIST
Adalgisa returns a classification determination and pathway recommendation with cited regulation, a dossier table of contents mapped against required data elements with gaps flagged, and a pre-submission deficiency-risk review.
Or have every skill inside your AI.
Questions before you buy? A person answers, usually the same day: hello@kissmyskills.com
// what's inside
What's inside this skill
- Regulatory pathway determined from actual risk classification, never the sponsor's preferred timeline
- Dossier table of contents mapped to the specific pathway's required data elements
- Draft dossiers reviewed for internal consistency and likely deficiency questions pre-submission
- Every requirement cited to a specific regulation, guidance document, or standard
Pharma and medical device teams navigating FDA/EMA approval, who need a defensible pathway strategy and a submission built to survive review.
What you're actually buying
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
- →Regulatory pathway determined from actual risk classification, never the sponsor's preferred timeline
- →Dossier table of contents mapped to the specific pathway's required data elements
- →Draft dossiers reviewed for internal consistency and likely deficiency questions pre-submission
- →Every requirement cited to a specific regulation, guidance document, or standard
📄 adalgisa-regulatory-affairs-specialist.skill
Under 2 min install
Works with Claude, ChatGPT & any AI chat
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.
// how to install
Under 2 minutes
Four steps. Any AI chat.
- 01Download the file
After checkout, the download link lands in your inbox. Save the file anywhere on your device.
- 02Open your AI chat
Claude, ChatGPT, Gemini, Grok, or Copilot - whichever one you already use.
- 03Paste the file contents
Drop it into the system prompt, Project instructions, or custom instructions field.
- 04Start working
Your AI is now configured as a specialist. Ask it anything inside its domain.
No technical knowledge required.
With Unlimited there is nothing to download. Connect your AI once, then just ask: "Load Adalgisa from KissMySkills."
// faq
Questions about this product
What does the Adalgisa skill do?+
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.
How do I install this skill file?+
Download the .skill package (it contains SKILL.md), paste the contents into Claude Projects Instructions or your AI's system prompt, add your own context and start your first session. Works with Claude, ChatGPT, or any AI chat that accepts system prompts.
Which AI tools does this skill work with?+
Works with Claude (recommended), ChatGPT, Gemini, Perplexity and Copilot, and any AI chat that accepts system prompts. Claude Projects gives the best results.
What is included in this download?+
One .skill package delivered instantly after purchase: the full SKILL.md role configuration plus a worked-example file with a real scenario so you see the quality before you rely on it. Pay once, keep forever, yours permanently.
How is this different from using Claude without the Adalgisa skill?+
Without a skill file your AI starts every session as a general assistant. With Adalgisa loaded it applies Regulatory Affairs Specialist (Pharma/Medical Device) methodology from the first message, with consistent quality every time. 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.
Do I have to read it myself?+
No. The file is written for your AI to read, not for you. Upload it or paste it in once and the AI takes on the role. After that you just ask it questions the way you normally would. You're welcome to open it and read it, but nothing here depends on you doing that.