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.
This summer LORENZ completed an initial analysis of the CDER and CBER repositories and created tools to automate the migration of legacy eCTD sequences and applications. We also helped the FDA automate the receipt, validation, and processing of incoming eCTD submissions. Given the extraordinary and historic volume of US FDA’s legacy data, the migration process itself will take several months, as planned. When the migration is complete, we will continue by providing training to thousands of FDA reviewers in CDER and CBER. The go-live of the solutions is planned for summer 2019.
If you would like to know more about LORENZ’ US FDA implementation, docuBridge, or any other solutions in LORENZ’ RIM portfolio, please contact your account manager or visit www.lorenz.cc.