ANDA Supporting Evidence Package

Technical preflight and supporting study artifacts for controlled human review

Planning workspace Draft artifacts Human review required CDISC support when applicable No submission gateway

eCTD Technical Preflight

Planning XML and structural checks; not publishing or agency validation

Create a draft planning artifact or run technical checks

CDISC SDTM

Supporting BE study data structure when required (DM, PC, EX)

Click to generate SDTM datasets

ADaM Datasets

Supporting analysis datasets when required (ADSL, ADPC, ADPP)

Click to generate ADaM datasets

CSR Tables

Clinical Study Report tables

Click to generate CSR tables

Supporting Report Drafts

Internal drafts that require scientific, regulatory, and authorized signatory review

Generate an internal supporting draft

Internal Review Bundle

ZIP of generated draft artifacts for controlled review

Generate a review bundle after checking each draft artifact

May include planning XML, study datasets, tables, and report drafts

Internal Review Checklist

Planning XML
SDTM (DM, PC, EX)
ADaM (ADSL, ADPC)
CSR Tables
FDA-format draft
EMA-format draft
ICH E9 (R1)
Define.xml
FDA Cover Letter
Qualified review pending

Scope: internal drafting, supporting study artifacts, and technical preflight only. This is not a validated publisher, validator, filing gateway, or compliance determination.

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