Validates clinical and nonclinical study-data packages against publicly described FDA technical-rejection criteria, SAS XPORT constraints from the Study Data Technical Conformance Guide, and an extensible catalog of SDTM, SEND, and ADaM structural conformance checks. Reads a study folder of CSV, RDS, or (when the suggested package haven is installed) SAS v5/v8 transport files, optionally checks define.xml, and writes a submission-style HTML and CSV validation report. This package is an independent open-source implementation. It is not affiliated with, endorsed by, or a copy of Pinnacle 21, Certara, or the FDA.