Released a new version of eCTDmanager 8.0 EXTEDO July 21, 2021

Released a new version of eCTDmanager 8.0 EXTEDO

Released a new version of eCTDmanager 8.0 EXTEDO  - the world's most popular system for electronic dossiers.

The new version of EXTEDO's eCTDmanager 8.0 is currently the most complete solution for managing registration dossiers (eCTD), supporting both EAEU and ICH standards.

Inpharmatis, the regional representative of EXTEDO in the CIS and Baltic countries, offers a new version of eCTDmanager 8.0, updated according to the latest regulatory requirements and the needs of the pharmaceutical market.

The eighth version of eCTDmanager EXTEDO allows to add documents from multiple storages, supports export in accordance with the EAEU requirements and allows to export of PDF documents either as embedded in an XML file or separately.

eCTDmanager EXTEDO is a one-stop filing dossier management software solution that meets the requirements for both electronic filings such as eCTD and NeeS and paper-based filing. The program makes it possible to simultaneously generate and store feeds for all world markets and allows you to manage feeds in different countries, observing regional requirements and conditions.

Also, thanks to the built-in mechanism for creating hyperlinks and bookmarks, the system makes it possible to detect, notify and fix broken links, which significantly improves the quality and consistency of registration dossier materials. This capability is most in demand for filing in highly regulated countries, such as for evaluating FDA and EMA dossiers. All changes made to the "parent" dossier are automatically inherited by the "child", eliminating the need for re-validation.

The eCTDmanager EXTEDO software solution has an intuitive interface, allowing you to easily form electronic applications without knowing the principles of XML-document generation. Built-in technical validation ensures that the application is created in accordance with the latest verification criteria provided by the regulators.

eCTDmanager EXTEDO is an advanced software solution from the world leader in the development and implementation of electronic solutions for the pharmaceutical industry, which has been tested by thousands of users and is trusted by more than 35 regulators around the world.

Inpharmatis provides its clients with services for the implementation of EXTEDO electronic solutions, user training, and technical support. For more information, you can contact info@inpharmatis.com