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AI agent for regulatory affairs specialists

Global Registration Requirements Matrix Agent

A requirements matrix and timeline for each target market, with document gaps listed

ResearchComplianceLegal
See how it worksGet access
Global Registration Requirements Matrix Agent: what goes in, what the agent does and what you get

What it does

When a product is planned for new markets, the team must know what each country requires: a local agent, testing, translations, fees and review times. Gathering this by hand takes weeks. This agent searches official sources for each target country's registration route and lists requirements, fees and review times. It checks that each source is current and clear; sources older than 12 months or vague ones are marked for confirmation with a local consultant. It compares the requirements with the company's document index to find gaps, treating missing local testing as a blocking gap. It then estimates the earliest submission and approval dates. The regulatory lead approves the market plan. Edge case: if a country accepts a reference approval from another market, the matrix shows that faster path.

How it works

Follow the arrows from top to bottom. The orange dashed arrow is the loop: when a check fails, the agent goes back and tries again.

Start and resultWhat it doesA check on its own workWaits for your OKGoes back and retries
Yes, continueApprovedNo 1 STARTS WHEN New markets proposed 2 USES A TOOL Search official sources for each country'sregistration route 3 DOES List requirements, fees and review times per country 4 CHECKS THE RESULT Is each country's source current and clear? If not: mark for confirmation with a local consultantand continue. Back to step 2. 5 USES A TOOL Compare requirements with the document index 6 DOES Estimate earliest submission and approval dates 7 YOU APPROVE Regulatory lead approves the market plan 8 RESULT Requirements matrix and timeline
Read the steps as a list
  1. New markets proposed
  2. Search official sources for each country's registration route
  3. List requirements, fees and review times per country
  4. Is each country's source current and clear?If not: mark for confirmation with a local consultant and continue. Back to step 2.
  5. Compare requirements with the document index
  6. Estimate earliest submission and approval dates
  7. Regulatory lead approves the market planThe agent waits here for your OK.
  8. Requirements matrix and timeline

How it decides

It picks the fastest legal route per country, using reference approvals where accepted, and counts a requirement as met only if the document exists and is valid for that country.

  • Use reference approval routes where allowed
  • Sources older than 12 months need confirmation
  • Missing local testing is a blocking gap

Make it yours

Every agent is a starting point. You choose these settings for your own situation.

  • Target countries
  • Source age limit (default 12 months)
  • Matrix columns
  • Who confirms unclear requirements

What keeps you in control

It always asks you first

  • Regulatory lead approves the plan
  • Engaging consultants or local agents is a person's decision

Hard limits

  • Does not engage outside parties
  • Marks any unconfirmed requirement clearly

It stops when

  • Done: all target countries assessed
  • Stop: product classification not set

Set it up

We guide you through the set-up, step by step

Members get the full set-up guide for this agent. No technical skills needed: you copy, paste and upload.

10 minto set it up in your AI
5 AIsChatGPT, Claude, Copilot, Gemini, Grok
  • One set of instructions to paste into your AI, with the clicks for ChatGPT, Claude, Microsoft 365 Copilot, Gemini and Grok
  • The agent then walks you through connecting your own data, one source at a time
  • A downloadable copy with the flow chart, the rules and the full guide
Get access to this agent

An example run

What happensFor a skin care device entering 5 markets, Brazil required local testing the company lacked, and Saudi Arabia accepted the CE certificate as a reference. The Mexico guidance found was from 2022, so the source check failed and the agent marked it for consultant confirmation. The consultant confirmed it on Jan 15. Earliest submissions ranged from 6 weeks to 7 months, and the regulatory lead approved the plan.

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