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DnXT Blog
Expert insights on regulatory operations, eCTD publishing, and digital transformation in life sciences.
EXTEDO eCTDmanager Review: Features, Limitations, and Modern Alternatives
EXTEDO eCTDmanager supports an extensive range of submission formats: eCTD v3, eCTD v4, NeeS, ACTD, eCopy, IMPD, PIP, VNeeS, DMF, ASMF, Clinical Trial Applications, and other regional formats including EAEU....
How CROs Can Scale Regulatory Publishing Without Adding Headcount
Before solving the scaling problem, it's worth understanding what sponsors evaluate when choosing a CRO for publishing services:
eCTD 4.0: What Regulatory Teams Need to Know About the Transition
eCTD 3.x: Uses a Document Type Definition (DTD) to define the XML backbone. The DTD specifies elements, attributes, and their relationships in a relatively rigid structure.
21 CFR Part 11 Compliance for Cloud-Based Regulatory Systems: What You Need to Know in 2026
When Part 11 was written in 1997, enterprise software lived on servers in your data center. You controlled the hardware, the network, the backups, and the physical security. Compliance was...
eCTD Publishing Software Comparison 2026: A Buyer’s Guide for Regulatory Teams
Before diving into individual platforms, here's the framework regulatory teams should use when evaluating tools:
Veeva Vault RIM Pricing in 2026: What Life Sciences Companies Actually Pay
Veeva does not publish list prices. All pricing is negotiated directly with Veeva's sales team, typically under NDA. However, industry analyses and user reports provide a reasonable picture of what...
Building a Scalable Regulatory Operations Strategy for 2025
The regulatory landscape continues to evolve at an unprecedented pace. Between expanding global filing requirements, increasing agency expectations for electronic submissions, and the ongoing integration of AI and automation technologies,...
The True Cost of Manual eCTD Submission Management
Many life sciences companies continue to manage eCTD submissions through a patchwork of spreadsheets, shared drives, and manual processes. On the surface, this approach seems cost-effective—no software licenses, no implementation...
How to Prepare for FDA 21 CFR Part 11 Compliance Audits
FDA 21 CFR Part 11 compliance isn’t optional for life sciences companies managing electronic records. Yet many organizations only think about compliance when an audit is imminent—leading to stressful scrambles...
5 Signs Your Regulatory Document Management System is Holding You Back
As a Director of Regulatory Operations, you’ve likely built your document management processes around a system that once seemed adequate. But as submission volumes grow and regulatory requirements evolve, the...
For Regulatory Operations Leaders: Building a Technology Strategy That Scales
For Regulatory Operations Leaders: Building a Technology Strategy That Scales If you lead regulatory operations at a growing pharma or biotech company, you have likely been handed a mandate that...
Enterprise Security for Regulated Cloud Platforms: A Senior Leader’s Checklist
Enterprise Security for Regulated Cloud Platforms: A Senior Leader’s Checklist When you propose a cloud-based regulatory platform to your organization, you will face two audiences: the business stakeholders who want...
