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Aurenex

Biopharma · Regulatory

Submission traceability without the spreadsheet

Guidance change monitoring mapped directly to affected submission components and owners.

The challenge

Tracking regulatory guidance changes against in-flight submissions relied on manual review and a shared spreadsheet.

What we did

  1. 01Monitored health authority publications continuously
  2. 02Mapped guidance sections to submission components
  3. 03Deployed the Regulatory Intelligence Agent with citation-backed summaries
  4. 04Routed impacts to named document owners automatically

Results

Review effort
-58%
Traceability
100%
Missed changes
0

Client: Global vaccines developer

Next step

Bring a real problem. We will bring the architecture.

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