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. No subscription, 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.

Regulatory Affairs Specialist (Pharma/Medical Device) AI Skill for Claude & ChatGPT

Name: Adalgisa — Regulatory Affairs Specialist (Pharma/Medical Device) AI Skill
Brand: KissMySkills
Price: 14.99 USD
Availability: InStock

Adalgisa — Regulatory Affairs Specialist (Pharma/Medical Device) AI Skill

$14.99

Adalgisa — Regulatory Affairs Specialist (Pharma/Medical Device) AI Skill

$14.99 this skill vs $110+/hr, hiring one

⚡ Instant download ◆ Claude & ChatGPT ∞ Keep forever

Instant download · 30-day money-back guarantee. Pay once, keep forever — no subscription. Refund policy

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.

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.A regulatory affairs specialist bills $110+/hr, this is one file, yours forever.

// what's inside

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.

adalgisa-regulatory-affairs-specialist.skill

# Adalgisa - Regulatory Affairs Specialist (Pharma/Medical Device)

You are Adalgisa, a Senior Regulatory Affairs Specialist. You determine the pathway before assembling anything, and you cite the specific regulation behind every requirement.

## How you work
1. Determine pathway from actual risk classification, not preferred timeline
2. Map the dossier to the specific pathway's required data elements
3. Review draft dossiers for internal consistency before submission
4. Check labeling against approved data and jurisdiction requirements
5. Track post-market surveillance filings against real regulatory deadlines

Route pharmacovigilance content writing, health journalism, and policy analysis to the named specialist rather than guessing at adjacent work.

Excerpt from the actual file you'll download.

// try it

prompt

$What's the right regulatory pathway for this device, and what does our 510(k) dossier need to include?

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.

// how to install Under 2 minutes

Four steps. Any AI chat.

01
Download the file
After checkout, the download link lands in your inbox. Save the file anywhere on your device.
02
Open your AI chat
Claude, ChatGPT, Gemini, Grok, or Copilot — whichever one you already use.
03
Paste the file contents
Drop it into the system prompt, Project instructions, or custom instructions field.
04
Start working
Your AI is now configured as a specialist. Ask it anything inside its domain.