An all new "Submission Hub" to locate your submissions NEW

With docuBridge 5.2, we have completely re-designed the docuBridge Explorer, which is your hub to find and locate your submissions based on pre-defined meta-data. Use dynamic filters to locate your submissions based on - for example - projects, countries or a status. Automatically create project folders dynamically to group certain submission types and their content.

Submission Replication

docuBridge 5.1 SP2 adds a significant feature that will save you time during assembly and compilation and also reduce the potential for errors: Submission Replication.

Submission Replication allows you to replicate the compilation changes made in one submission sequence in other submission sequences and even in other Applications. Applications may be related for a variety of reasons, for example a single product marketed around the world or national authorisations for and EU ASMF organized in parallel eCTDs.

Regulated Production Submission (RPS / eCTD 4.0) Publishing (Alpha)

With docuBridge 5.1, we have already implemented an Alpha version of RPS Publishing, also known as eCTD 4.0. This means that you do not have to worry: you do not have to change systems or learn new processes - the RPS publishing option is simply another publishing module within docuBridge.

At LORENZ, we are also a voting member of Health Level Seven (HL7), that develops the RPS standard.

Simultaneous Multi-User Editing

If you work in teams you may need to work on a single submission sequence in parallel. docuBridge 5 brings this to you! As soon as you edit a node in the table of contents, docuBridge will immediately lock down that section so others can only view, rather than edit, that same node.

Inherit & Auto-Update Sequence Components across many Sequences

You can create copies of an existing sequence and start working on them in parallel, therefore not requiring you to complete one, before you begin the other.

Not only do you inherit all of the submission components found in your base submission, but in fact if you make any changes in a follow-up sequence, it will automatically update the others too!

Regional Administrative Data Editor

The eCTD contains more than just documents - it also transports quite a bit of data. And pending on where you want to submit, this required data changes from region to region.

docuBridge 5 has an Administrative Data Editor that easily allows you to edit, manage and re-use information typed in once. This is particularly useful in Europe, where you may be required to submit only slightly differing data to the various countries for certain submission procedures.

Visually Spot the Differences between Submission Sequences

When you are compiling or reviewing a submission, finding the difference between one sequence and another can sometimes be a cumbersome task. Especially, if you don't want to switch backwards and forwards betwen sequences to do so.s

docuBridge 5 has a very simple slider that fades out those differences and easily fades them back in again - all without having to leave your current submission sequence!

Exchange more than just eCTD data between Partners: Submission Exchange™

The ICH eCTD specifications specifically highlight that the eCTD was not designed as a transport mechanism between industry. It's role is purely to submit the required information to the agencies. But what if you work with multiple partners, CROs, or plan to license a submission and need more than what is in the submission itself?

Users of docuBridge 5 can make use of the Submission Exchange feature. Rather than focusing only on the submission and submission lifecycle, the Submission Exchange feature actually allows you to exchange document lifecycle information as well. That may you can continue maintaining the documents in your environment, even if their life started somewhere else!

Multiple Languages: docuBridge speaks them too!

Sometimes it's easier to work in your own language. For that reason, docuBridge 5 comes built-in with the following languages: English, French, German, Japanese and Polish. Users can select their language preferences on-the-fly.

AMNOG Publishing

We are the first submission management and production system to implement the AMNOG (Arzneimittelmarktneuordnungsgesetz) eSubmission standard. This standard is somewhat different in both content and format to the more commonly known standards, such as eCTD and NeeS.

AMNOG is a law regulating the reimbursement of drugs within Germany's statutory health care system. With docuBridge you are able to generate AMNOG submissions in the same way you generate any other type of submission. You can even re-use content from other submissions in your AMNOG submission, thereby reducing your compilation and QA times.

Learn more in German (this link takes you to an external site)

Learn more in English (this link takes you to an external site)

Paper Publishing: You still need it!

We have enhanced some of our paper publishing capabilities, with more options for tab & slip sheets as well as volumization.

You do not need to create a separate submission to create a paper version - simply change your output from electronic to print!