Regulatory Submission Tools: A Guide to RIM & eCTD Software
An overview of regulatory submission software for the life sciences. Learn how RIM systems & eCTD publishing tools streamline compliant filings to the FDA & EMA
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Articles tagged with “regulatory-submission”
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
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
Accelerating Pharma Regulatory Submissions: A Guide
Explore key strategies for accelerating pharma regulatory submissions. Learn about expedited pathways, process redesign, and the role of AI in shortening drug a
Pharma Regulatory Submissions: Challenges & Digital Solutions
Explore key challenges in pharmaceutical regulatory submissions, from legacy eCTD issues and CMC gaps to the rise of AI and structured data for faster drug appr
A Guide to CDISC Standards: Understanding SDTM and ADaM
Learn the essential CDISC standards for clinical trial data. This guide explains the SDTM and ADaM data models, their structure, and use in regulatory submissio
CDISC Standards: How They Work with SDTM & ADaM Examples
Learn about CDISC standards for clinical trial data. This guide explains SDTM, ADaM, CDASH, and Define-XML with concrete examples for regulatory submissions.
Git Version Control for FDA and IEC 62304 Compliance
Examines how to apply Git version control workflows to satisfy FDA compliance, covering traceability, audit trails, and standards like 21 CFR Part 11 & IEC 62304.