For pharmaceutical teams running agents in production: the governance layer needs to match the rigour already applied to traditional systems.
The pharmaceutical context
21 CFR Part 11 electronic records requirements and GxP validation overlay make audit evidence and change control essential.
Regulatory backdrop
- FDA 21 CFR Part 11
- GxP
- EU AI Act →
- GDPR →
- HIPAA →
- ICH guidelines
Common agent use cases
- Pharmacovigilance agent processing adverse event reports
- Regulatory submission drafting agent
- Medical affairs literature review agent
- Clinical trial protocol drafting agent
- Patient adherence outreach agent
- Manufacturing deviation classification agent
Use case pages
Typical buyers
- CISO
- Head of GxP IT
- Head of Pharmacovigilance
- Head of Regulatory Affairs
- Chief Compliance Officer
Talk to a specialist
Most deployments start with a 30-minute scoping call.
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