AI agent for medical writers
Health Authority Query Response Agent
A complete, consistent response to every agency question before the deadline
What it does
During a review, the health authority sends a question letter with a deadline, often 30 to 90 days, and answers come from many expert teams. This agent splits the letter into individual questions and sub-parts, assigns each to an owner and sets internal due dates 10 days before the agency deadline. It collects draft answers and checks each one against the original question: every part must be addressed and data must match the submitted dossier. If not, it returns the answer to the owner with the gap listed. It then assembles the full response document. The regulatory lead approves and submits it. Edge case: if an answer introduces new data not in the original submission, it is flagged so the lead can decide whether it changes the file.
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.
Read the steps as a list
- Question letter received
- Split the letter into individual questions and parts
- Assign each question to an owner with internal due dates
- Collect draft answers
- Does each answer address every part and match dossier data?If not: return the answer to the owner with the gap listed. Back to step 4.
- Assemble the response document
- Regulatory lead approves and submitsThe agent waits here for your OK.
- Response submitted and tracked
How it decides
An answer passes when it addresses every part of the question and its data matches the dossier or is marked as new data.
- Internal due dates are set 10 days before the agency deadline
- New data is always flagged
- Each sub-part needs its own answer
Make it yours
Every agent is a starting point. You choose these settings for your own situation.
- Internal buffer before deadline (default 10 days)
- Owner mapping by question type
- Response template
- Reminder frequency
What keeps you in control
It always asks you first
- Regulatory lead approves and submits the response
Hard limits
- Never submits to the agency
- Does not change submitted dossier documents
It stops when
- Done: response submitted
- Stop: agency extends or withdraws the request
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.
- 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
