eCTD submissions in China – next step has been taken

In November 2018, we released a press release regarding the Chinese NMPA, noting that the agency selected our docuBridge and eValidator solution as an eCTD data management system. Now, the next step has been taken towards introducing eCTD submissions in China.

The CDE of the NMPA published the Chinese eCTD specification on March 1, 2019. Comments are appreciated until April 1, 2019. This marks an important milestone in China´s eCTD project, beginning the countdown to the final implementation of eCTD submissions in China.

Because of our involvement in this project, we can offer our customers around the world a head start in meeting China´s new eCTD submissions requirements. Please feel free to contact us or ERIS, our distributor for LORENZ e-regulatory affairs solutions in mainland China, regarding inquiries and further collaboration.

LORENZ eValidator 18.2.1 Setup updated

The original packaging of the eValidator 18.2.1 release shows a false negative for US eCTD rule 5030.

To correct this, we have just updated the eValidator 18.2.1 setup, which is available for download immediately. If you installed the package before February 4, 2019, please download and install the latest version or run a repair installation in the Windows control panel to resolve the issue. Continue reading

We wish you a reflective, joyous holiday season and a happy new year!

As 2018 draws to a close, all of us here at LORENZ would like to wish you a joyous holiday season and a very happy new year!

To celebrate the festive season, we are making a donation to the LORENZ Foundation to support their social work; in particular their “Arche Noah” inclusion project. Continue reading

LORENZ docuBridge, eValidator and Automator implementation progressing at US FDA – Preparing to migrate 1.3 million eCTD sequences

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.

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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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