Regulatory Submission Intelligence
Part of the Sutra Suite·Sutra Submit
Submission intelligence that finds the gaps before the agency does.
A Complete Response Letter (CRL) is one of the most expensive outcomes in pharmaceutical development. Sutra Submit gives Regulatory Affairs teams AI-powered insight into submission readiness — before the package leaves the building.
What Regulatory Affairs teams deal with.
- ●Cross-module inconsistencies in data, terminology, and claims.
- ●Submission content that drifts from current guidance over a multi-year program.
- ●Missing evidence or insufficient data hidden inside a large submission.
- ●No structured way to score submission readiness before filing.
- ●No durable audit trail of the references and decisions that shaped the submission.
A Complete Response Letter (CRL) typically costs that much in delay — and tens of millions in lost revenue.
Source: Industry-reported benchmark
How Sutra Submit works.
AI scans across all Common Technical Document (CTD) modules to detect inconsistencies in data, terminology, and claims before submission.
Maps submission content against current Food and Drug Administration (FDA) and International Council for Harmonisation (ICH) guidance to flag gaps and misalignment.
Identifies where required data, studies, or documentation appears absent or insufficient relative to regulatory expectations.
Produces a structured readiness score across modules — flagging high-risk areas before they become Complete Response Letters (CRLs).
A continuously updated log of all guidance references used, decisions made, and changes tracked through the submission lifecycle.