Tag Archives: USFDA

International Trends in Drug Registration and Evaluation [Part 3: ISO IDMP and the MPID]

Summary of part 1 and 2:

In our last blog posts of the series you were informed about eCTD v3.2.2 and eCTD v4.0. The articles resolved around the advantages of eCTD v3.2.2 over paper or non-eCTD electronic submissions and the improvements from eCTD v4.0 over eCTD v3.2.2. If you have not read it, you will find the first article here and the second article here.

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LORENZ docuBridge, eValidator, and Automator making their debut at the USFDA

The LORENZ implementation team was on-site at the USFDA headquarters in Silver Spring, Maryland between April 30 and May 4, 2018, to discuss the implementation process and to begin the training of agency personnel in LORENZ solutions within its RIM portfolio.
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