Regulatory eSubmissions, LLC can assist your organization in an objective evaluation of your current or proposed eCTD assembly processes. 

With over a decade of experience optimizing submission production processes we have the ability to recognize simple, frequently overlooked standardization and process changes, which can bring significant benefit in efficiencies, cost savings and can expedite your regulatory submission.

An example is presented below which provided significant savings in resources and expedited delivery to the FDA.  There are other potential opportunities which may be uncovered as a result of a thorough unbiased observation and assessment of your current or proposed eCTD production processes.

Annotated label citation and automation example.  A standard citation methodology was developed and adopted for the authoring of the annotated label.  This standardization enabled the implementation of automation for the hypertext linking required for this submission component.  Automation dramatically reduced the amount of time necessary to produce this regulatory filing component; the time needed to incorporate the links went from hours to minutes.  Additionally the amount of quality control/hypertext link verification dramatically reduced.  The annotated label can be a rate-limiting component for the delivery of the regulatory submission.  This automation in some cases resulted in an expedited (1-3 days early) submission to the FDA.