Ennov NeeS Software Publisher

Publish and submit your NDAs x2 faster with Ennov Nees Publishing tool.

Business issue

Regulatory Affairs Department of Life Sciences companies need support to face the challenges of ever-evolving international regulations, increased globalization and redefined stakeholders. Ennov offers a proven Publisher to help you publish and submit all major application types, including INDs, NDA/ANDAs, DMF/PMFs, MAAs and NDS/ANDS in all specific regional formats required by regulatory agencies worldwide.

Benefits

  • Submit your dossier twice as fast.
  • 30% reduction in workload.
  • Fast access to your publications

Ennov NeeS Software Publisher

NeeS Software Publisher is a complementary add-on to the Ennov Regulatory solution, designed for the pharmaceutical companies’ Regulatory Affairs Departments. Automation of the NeeS publishing format of the NDA dossiers created with Ennov NeeS software offers significant benefits.

  • Document availability and aggregation
  • Draft publishing
  • Internal compliance check

Ennov Nees Software makes NeeS publishing as simple as your everyday document management. The NeeS Software Publisher  provides you with dossier templates complying with the ICH NeeS specifications. Starting from a template, you can decide at any time to publish the entire NeeS dossier, or just a sub-dossier that will be inserted into the whole NeeS dossier. It also enables to duplicate dossiers, thereby allowing them to be reused for submission in a new region.

NeeS Software includes sophisticated hyperlink management features.

Checks are automatically run on the links of all the PDF documents included in a dossier and invalid links are systematically reported. Therefore with Ennov NeeS Software you can modify the links to make them valid and insert “submission” links. This tool contains an internal NeeS compiler. The validation feature allows any non compliant element of the dossier to be reported (incorrect file name, missing item, etc.), while providing a direct access to the invalid element, and thereby making all necessary modifications possible before NeeS publishing starts. Ennov NeeS Software integrates the creation of several tables of contents (one global table of contents and additional tables created by module), in full compliance with the guidelines. As is the case for the paper publishing, a draft NeeS publishing can be generated, allowing you, for example, to check the hyperlink browsing validity throughout the dossier creation phase. The NeeS Software is, of course, compatible with all the paper publishing features. In other words, for the same source dossier, you can manage both paper and NeeS publishing.

Ennov Dossier stores the NeeS publishing result in a repository: any agency-submitted NeeS application is identically and securely stored in Ennov. You can directly view the publishing from the NeeS Software.
NeeS Software publisher is fully compliant with the FDA’s 21 CFR Part 11 requirements.

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