How eCTD v4Ready Evaluates Submissions

1. XML Parsing & Link Verification

The engine inspects eCTD v3.2.2 sequence backbones (`index.xml` and regional XML files). It parses all <leaf> tags and traces cross-references made via modified-file attributes to verify lifecycle link integrity prior to v4.0 transition.

2. Context of Use (CoU) Readiness Check

In eCTD v4.0, free-text leaf titles and attributes are replaced by Context of Use (CoU) codes and Controlled Vocabularies (CVs). The application evaluates title structures to detect non-standard naming and missing titles that require remediation.

3. AI Regulatory Narrative Generation

Using the Together AI interface configured in your local environment, the system synthesizes key findings into a short operational summary, highlighting specific lifecycle and metadata risks for regulatory operations teams.