Before solving the scaling problem, it's worth understanding what sponsors evaluate when choosing a CRO for publishing services:
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.
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 complex but conceptually straightforward: you could point to the server room and say "our records are ther
Before diving into individual platforms, here's the framework regulatory teams should use when evaluating tools:
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 companies actually pay.
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, Directors of Regulatory Operations face a pivotal moment. The strategies and systems you put in place now will determine whether your organization leads or lags […]
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 projects, no change management. But the true cost of manual submission management extends far beyond what appears on any budget line. The Hidden Costs of […]
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 and potential findings. This guide provides a systematic approach to audit preparation that regulatory operations leaders can implement today. Understanding What FDA Inspectors Look For […]
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 cracks begin to show. Here are five warning signs that your current regulatory document management system is creating bottlenecks instead of enabling efficiency. 1. Your […]
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 sounds simple and is not: modernize the technology stack, reduce submission cycle times, and do it without disrupting the work that is already in flight. […]
