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.
- Submit your dossier twice as fast.
- 30% reduction in workload.
- Fast access to your publications
Ennov NeeS Software Publisher
- 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.