In response to questions about our ongoing implementation project at the US FDA, we would like to share a short update with you.
In our previous blogpost, we announced the need to migrate approximately 1.3 million legacy eCTD sequences into our docuBridge solution and make them available to US FDA reviewers.
We would like to provide our customers and the industry with an update on the status of LORENZ’ implementation of LORENZ docuBridge, eValidator, and Automator at the U.S. Food and Drug Administration (FDA).
(Please click here to read our previous blogpost including a timeline of events from 1 July 2016 – 30 May 2017.)
We at LORENZ have been receiving an increasing number of emails and phone calls from our customers and partners concerning the current state of the project implementing LORENZ docuBridge, eValidator, and Automator at the U.S. Food and Drug Administration (FDA).
In order to clarify the chain of events and alleviate any concerns, we are outlining below a timeline of events we hope will be helpful.