Solutions
For enterprise customers in the life sciences industry, the most high-value AI agentic automation scenarios focus on workflows that are
multi-step
evidence-heavy
regulated
require cross-functional coordination
expensive when done manually
Thunk.AI is a horizontal AI agentic automation platform, offering best-of-breed differentiated capabilities for high AI reliability, no-code authoring by process owners, easy customization, and rapid time to deployment.
Thunk.AI does NOT displace your existing regulatory information systems, quality management platforms, or pharmacovigilance databases. It layers on top of them, automating tedious and complex human workflows, reducing response times, reducing errors, and driving ROI.
Top-of-mind for pharmaceutical manufacturers, biotech companies, and regulated life sciences organizations because they:
Sit at the intersection of compliance, speed-to-market, and operational efficiency
Are painfully manual today
Require reasoning + orchestration + auditability
Regulatory Affairs & Submissions
CMC Variation & Post-Approval Changes
Regulatory Intelligence & Horizon Scanning
Submission Lifecycle Management
Clinical Operations
Clinical Trial Document Automation
Protocol Deviation Assessment
Safety Narrative Generation
Pharmacovigilance & Safety
DSUR/PBRER Generation
Adverse Event Case Processing
Signal Detection & Management
Compliance & Audit
Audit Response Preparation
GxP Compliance Monitoring
SOP Management & Training
Quality & Manufacturing
CAPA & Root Cause Analysis
Deviation Management
Batch Record Review
AI Reliability
Accuracy in regulatory interpretation
Consistency across submissions
Policy and guideline compliance
Explainability & Auditability
Complete decision traces
Source document attribution
21 CFR Part 11 compliance
Human-in-the-Loop Control
Approval gates at critical steps
Expert review workflows
Override and escalation logic
1
Initial Adoption
CMC variations
CAPA management
Safety reporting
2
Expansion
Regulatory intelligence
Deviation management
Clinical documentation
3
Mature
End-to-end regulatory ops
Continuous quality monitoring
Autonomous compliance workflows (with guardrails)
Thunk.AI offers private deployments on any of the hyperscalar cloud platforms.
Thunk.AI is an AI solution partner on the Google Cloud Platform marketplace, implementing deep technical integration with GCP and Gemini, and payment integration within the GCP billing and procurement system.
