Regulatory Affairs
Assemble submission evidence, route review workflows, and preserve the reasoning behind every decision.
- Submission package support
- Evidence expectations and gaps
- Traceable review operations
Post-discovery operating layer
Premise Bio is building AI agents that learn each team's standards, review patterns, evidence expectations, and operating logic, then help regulated work move with traceability and right-first-time quality.
Platform
Premise focuses on the operational terrain after discovery, where scientific evidence becomes controlled plans, documents, reviews, and decisions.
Assemble submission evidence, route review workflows, and preserve the reasoning behind every decision.
Support protocols, study startup, controlled documentation, and monitoring workflows with governed AI assistance.
Help teams manage evidence response, review standards, and scientific communication workflows with consistent context.
Design partners
Premise Bio is working with pharma teams to define where AI can improve speed, rigor, and accountability across regulated execution.
We are looking for regulatory, clinical operations, and medical affairs leaders who want to help shape the first governed AI workflows.
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