Rehearse FDA-facing statements, recall communications, IR messaging, and M&A announcements against simulated cohorts. Automate clinical and operations workflows with audit-grade decision trails.
Pharmaceutical companies operate at the intersection of FDA regulation, high investor sensitivity, and large-scale clinical and commercial operations. Isaiah handles the highest-stakes communications — FDA-facing statements, recall and adverse-event communications, IR messaging on clinical milestones, M&A announcements. Beth (in build) handles operations — clinical document review, vendor management at trial scale, compliance monitoring across 21 CFR Part 11 and international frameworks.
FDA-facing statements carry regulatory, investor, and patient reaction risk simultaneously
Recall and adverse-event communications must satisfy FDA + parallel regulators internationally + patient and clinician communities
Clinical document review at trial scale strains regulatory affairs bandwidth
21 CFR Part 11 compliance demands deployment posture and audit governance most general-purpose AI doesn't provide
Isaiah rehearses FDA-correspondence and public statements against FDA, oversight, patient advocacy, investor, and press cohorts. — via isaiah.
Pre-rehearse IR communications on clinical-trial results, FDA decisions, and pipeline updates against investor cohorts. — via isaiah.
Beth managed agents review clinical documents at trial scale with full audit trails. — via beth.
Beth agents monitor compliance posture across 21 CFR Part 11 and international pharma regulatory frameworks. — via beth.
Yes. Both products support deployment postures (VPC, on-prem, air-gapped) compatible with 21 CFR Part 11 audit and validation requirements. Pilot scoping covers Part 11 scope explicitly.
Yes. Per-regulator cohorts are configurable so candidate statements can be rehearsed across FDA, EMA, PMDA, and other international regulators in parallel.
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