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AI agent for regulatory affairs specialists

Annual Report and Periodic Safety Filing Agent

Assemble a complete, consistent periodic report on time without chasing data by hand.

ReportingAdministrationLegal
See how it worksGet access
Annual Report and Periodic Safety Filing Agent: what goes in, what the agent does and what you get

What it does

Annual and periodic safety reports need data from many teams, and late data delays the filing. The agent lists the required sections and their sources, requests data from each owner with a due date, and checks each submission for completeness and for consistency with last year's report. It chases gaps with a message suited to the problem. When all sections are in, it assembles a draft with a summary of changes. The specialist approves the report before filing. Edge case: a complaints count is down 40 percent from last year without an explanation, so the agent asks the owner to confirm it before using it.

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, continueYes, continueApprovedNoNo 1 STARTS WHEN Reporting period closes 2 USES A TOOL List required sections and their owners 3 USES A TOOL Request data from each owner with a due date 4 DOES Check each section for completeness and format 5 DOES Compare each section with last year's report 6 CHECKS THE RESULT Is each section complete and consistent, orexplained? If not: Return it to the owner with the specific gap anda new date. Back to step 3. 7 USES A TOOL Chase overdue owners 8 CHECKS THE RESULT Are all sections in 14 days before filing? If not: Escalate overdue sections to the specialist andagree a plan. Back to step 3. 9 DOES Assemble the draft with a list of changes 10 YOU APPROVE Specialist approves the report before filing 11 RESULT Approved draft report
Read the steps as a list
  1. Reporting period closes
  2. List required sections and their owners
  3. Request data from each owner with a due date
  4. Check each section for completeness and format
  5. Compare each section with last year's report
  6. Is each section complete and consistent, or explained?If not: Return it to the owner with the specific gap and a new date. Back to step 3.
  7. Chase overdue owners
  8. Are all sections in 14 days before filing?If not: Escalate overdue sections to the specialist and agree a plan. Back to step 3.
  9. Assemble the draft with a list of changes
  10. Specialist approves the report before filingThe agent waits here for your OK.
  11. Approved draft report

How it decides

A section is accepted when it is complete, in the right format and consistent with last year, or the difference is explained. Otherwise it returns to the owner with the specific problem.

  • Return any section with a change over 25 percent that has no explanation
  • Chase owners 14, 7 and 3 days before their due date
  • Format follows the regulator template
  • Escalate any section more than 7 days late

Make it yours

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

  • Reporting calendar and deadlines
  • Change threshold needing an explanation (default 25 percent)
  • Chase schedule
  • Report template

What keeps you in control

It always asks you first

  • Specialist approves the report before filing
  • Specialist approves escalations to senior leaders

Hard limits

  • Never files the report
  • Never edits data supplied by an owner

It stops when

  • Done: report approved and filed by the specialist
  • Stop: a section cannot be completed in time, so the specialist decides

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 happensThe agent requested 9 sections. The complaints section showed 41 percent fewer cases than last year with no note, so the consistency check failed. It asked the owner, who explained a new triage rule and attached the definition. The clinical section was 9 days late and was chased twice. The specialist approved the assembled draft 10 days before filing.

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