How Unwritten Agency Rules Affect eCTD System Migration
Feb25

How Unwritten Agency Rules Affect eCTD System Migration

The true challenge of eCTD migration is your impact analysis (i.e. downtime, architectural changes and environmental changes) and determining whether or not your selected vendor supports unwritten Agency rules. Bear in mind that subtle differences exist among vendors who have implemented eCTD systems. You need to ensure that your chosen vendor has experience migrating submissions, not only from your existing system, but from all systems that generated eCTD that you now have to manage.

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Five Points to Consider When Selecting an Enterprise eCTD Viewer
Oct16

Five Points to Consider When Selecting an Enterprise eCTD Viewer

When selecting a system for cross-department viewing of eCTD submissions, as well as archiving, here are some important points you’ll want to give proper attention.

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How Mergers & Acquisitions Impact Regulatory Operations Part II

Executive management may consider creating a strategic plan for in/out-licensing and mergers and acquisitions. This strategic plan should include the technical aspects of such an undertaking. Such topics as systems to be used, network and security, and staff involvement (including when to involve staff) are important strategies to ensure success.

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Free Educational Webinar: Reasons to Switch to eCTD

Update: the webinar slides are now available for download here. The eCTD format continues to grow as the standard for regulatory submissions worldwide, and the FDA has made it very clear that it prefers to receive submissions in eCTD format. However, when many smaller biotech and pharma companies reach the IND or NDA/BLA stages, they still often consider paper submissions as a viable option. That’s why GlobalSubmit and Cato...

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Integrating Document Management and eCTD Publishing Systems
Apr26

Integrating Document Management and eCTD Publishing Systems

Most Tier I and Tier II sponsors maintain their submission documents in an electronic document management system (EDMS). It’s obvious that software that creates electronic (or paper) submissions must work with the documents managed in the EDMS. But what is not so obvious is the optimal integration between an EDMS and a publishing tool.

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