Regulatory Intelligence
Regulatory change, assessed at speed
A specialty pharma regulatory team could not keep up with constant change across more than twenty markets. We automated regulatory-impact assessment and health authority query triage, with regulatory experts validating every recommendation before action.
At a glance
- Client: A specialty pharma company
- Scope: Regulatory change across more than twenty markets
- Team: Regulatory Intelligence tools from Alethic Insights, with the client's regulatory experts
- Result: 50% faster assessment, with a full audit trail
- Area: Enterprise Engagement, Regulatory Intelligence
The challenge
The client's regulatory team tracked guidance, rules and health authority updates in more than twenty markets. New changes arrived every week.
For each change, someone had to read it, decide whether it affected the company, find the SOPs and documents involved, and plan the update. Health authority queries added to the load. Done by hand, assessments piled up, and the team could not easily show auditors how each decision was made.
Our approach
We automated the slow, repeat steps and kept every decision with the client's experts.
- Continuous scan: The tool watches regulatory sources in each market and flags new or changed guidance.
- Impact assessment: It compares each change with the client's SOPs and documents, lists the gaps and ranks them by priority.
- Query triage: Incoming health authority queries are sorted by topic and urgency, and matched with past responses and sources.
- Expert validation: Regulatory experts review every recommendation the tool surfaces before any action is taken. The tool suggests; people decide.
- Audit trail: Every source, assessment and decision is logged, so it can be shown to an auditor.
What we delivered
- Regulatory intelligence dashboard: critical gaps, SOPs waiting for update and sources being monitored
- Automated gap detection against the client's SOPs and documents
- Health authority query triage
- Document library and compliance search
- Built-in assistant for questions on regulations and documents
The result
50% faster assessment
Reduced manual review and fully audit-ready traceability.
The team now works from a continuous, prioritised view across markets, with each impact checked by an expert.