The CDE, China’s regulatory agency conducted an eCTD pilot from November 25th through December 4th 2019. A selected number of industry companies were nominated to submit electronic submissions in eCTD format (CN v1.0 DRAFT). Continue reading
The releases of docuBridge, drugTrack and eValidator are available!
What´s new in docuBridge? Several features have been improved, and we have made the webAccess Module, the web-based docuBridge, available to all docuBridge FIVE customers. webAccess now includes both the webAccess Submission Workbench and the new webAccess Explorer. Furthermore, docuBridge now lets you save time by offering an automated compilation option based on meta-data. Last but not least, the Document Management capabilities have been enhanced to help authors to standardize the authoring process. Click here to read more about these highlights: What´s new in docuBridge 19.2?
What´s new in drugTrack? This release features a wide range of improvements and one completely new module to make your work life easier. Via the new Master File Tracking module, you can track Drug Master Files in the US or Active Substance Master Files in Europe. We have also increased the number of standard reports, giving you a wider selection of pre-defined and detailed reports. In addition, should your company have more specific requirements, you have now the ability to create customer-defined configurable business objects. To make your workflow more fluid, we have enhanced drugTrack´s Warnings and Notifications for Marketing Authorizations. Click here to read more about these highlights: What´s new in drugTrack 19.2?
What´s new in the eValidator? We have made updates and corrections for CA eCTD, US eCTD and eCopy, CN eCTD, JO eCTD, CH eCTD, AU eCTD, EU eCTD, GCC eCTD, TH eCTD, and ZA eCTD.
The April releases of docuBridge, drugTrack and eValidator are available!
What´s new in docuBridge? Several improvements come with release 19.1. An enhanced page scaling option for print and other publishing formats is available, and more granular permission settings for administrators. Continue reading
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
Since June 1, 2018, the National Competent Authorities no longer accept veterinary submissions for Centralized Procedures via CD, DVD or Eudralink. This means that the EMA eSubmission Gateway / Web Client is now the only route for VNeeS submissions. Continue reading
The October releases of docuBridge, drugTrack and eValidator are available!
What´s new in docuBridge? Multiple user-friendly improvements have been made. Configurable column layout settings in the submission Continue reading
Several anti-virus scanning programs have started to report that installed docuBridge software (version 5.10 or higher) is infected with viruses or malware. Please note: Continue reading