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Pharma · Regulatory · 2025
A regulatory intelligence agent that keeps global submissions one step ahead.
An agent that monitors regulatory changes across 30+ authorities and pre-drafts impact assessments for the affected products and markets.
Client: Global pharma — regulatory affairs
30+
Authorities monitored
8×
Faster impact drafts
100%
Human-reviewed
The challenge
Regulatory affairs teams were tracking authority updates manually across dozens of jurisdictions, with impact assessments arriving too late to influence submission planning.
Our approach
- 01Connected authority feeds, internal product registers and submission history into one governed source.
- 02Built an agent that detects relevant changes, maps them to affected products and pre-drafts an impact assessment for human review.
- 03Designed with full audit trail and human sign-off on every assessment.
Outcome
- — Days, not weeks, from authority change to draft impact assessment.
- — Broader coverage across jurisdictions without adding headcount.
- — Earlier, better-informed submission planning.