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Reply to a regulator's questions clearly and on time
Turn a regulator's request for more information into a tracked list of questions, owners and a well-organised draft reply for review.
When to use it
When a regulator asks for more information
Step by step
Break the request down
Paste the regulator's letter or email into your AI assistant with this prompt.
Prompt to copyHere is a request for further information from [regulator] about [submission or matter], with a reply deadline of [date]. 1) List every question or request separately, numbered, quoting their wording. 2) For each, note the type of answer needed (data, document, explanation, commitment) and which team is likely to hold it. 3) Suggest internal deadlines working back from [date], allowing [5] days for review and sign-off. Present it as a table.Gather the answers
Send each question to its owner with the internal deadline, and collect their facts, data and documents.
Draft the response
Give the AI the owners' answers and ask: 'Draft a formal response that answers each numbered question in order, using only the facts provided. Refer to attachments by name. Mark anything incomplete as [OPEN]. Keep a factual, cooperative tone.'
Review and sign off
Check every statement against the evidence and have the response approved by the right people before it's sent. The AI draft is never the final word.
Track it
Log the request, the response date and any follow-up commitments in your regulatory tracker.
What you get
Q1 'Provide stability data at 12 months' | Data | QC lab | Due 8 Mar. Q2 'Explain the change to supplier of component B' | Explanation | Purchasing | Due 6 Mar. Q3 'Confirm label version in use' | Document | Regulatory | Due 5 Mar. Sign-off 11 Mar, send by 15 Mar.
Tips
- Ask the AI to check that every numbered question has an answer before you send; missing one can restart the clock.
- Don't paste confidential submissions, customer details or personal data into a public AI tool unless your organisation allows it.