Articles tagged with “refuse-to-file”

eCTD Validation Errors: A Guide to Avoiding RTF

Learn the most common eCTD validation errors that cause Refuse-to-File (RTF) actions. This guide covers structural, XML, and PDF issues for successful submissio

35 min read

1/14/2026

ectd ectd validation errors regulatory submission refuse to file fda regulatory affairs xml backbone lifecycle management

Regulatory Submission QC Checklist: A Comprehensive Guide

A guide to regulatory submission quality control (QC). Explore best practices for eCTD dossier checklists to ensure compliance and avoid costly FDA/EMA rejectio

35 min read

1/13/2026

regulatory submission quality control qc checklist ectd ctd regulatory affairs dossier preparation fda submission drug approval process refuse-to-file