Whether you are an experienced publisher or brand new, efficiently publishing eCTD submissions can be challenging, especially if you’re a smaller pharmaceutical or biotechnology organization with limited resources and regulatory professional headcount. Therefore, the utmost efficiency in publishing your eCTD submissions is essential as your regulatory department races to meet deadlines and deliver treatments to patients.
With Certara’s GlobalSubmit PUBLISH eCTD software, you’ll greatly reduce the number of steps your regulatory professionals must perform to arrive at a validated, high-quality output.
PDF publishing tasks, such as adding external and internal hyperlinks, and performing QC of bookmarks and hyperlinks, account for 80% of your time spent on eCTD submission compilation.
GlobalSubmit CROSSCHECK and LINK functionality, both found within GlobalSubmit PUBLISH, are designed to facilitate these actions, which are necessary if sponsors want to create high-quality, compliant eCTD submissions in a more efficient manner.
Independent tests show that CROSSCHECK is 8X faster and 3X more accurate when compared to traditional, manual methods of hyperlink and bookmark QC. CROSSCHECK displays a link source and destination side-by-side for quick, easy review. This innovation expedites an activity that accounts for 40% of your working time when building your eCTD submissions.
LINK streamlines your workflow by cutting out at least four publishing tasks per document. Without exiting the GlobalSubmit PUBLISH interface to access a third-party tool, you can set PDF document properties, create bookmarks and hyperlinks, and apply headers and pagination. Document updates can then be processed in bulk at industry leading speeds.
GlobalSubmit PUBLISH eliminates tens of thousands of routine, annual publishing tasks while ensuring 100% regulatory compliant PDF documents through auto processing. When the option to automatically process PDF documents according to regulatory compliant settings is turned on, the system only produces compliant PDFs. Time savings are realized as manual, pre-publishing tasks previously performed by the user are now executed by the system. Regulatory compliant PDF properties include:
- Set navigation to bookmarks panel and pag
- Embed all fonts
- Inherit zoom for bookmarks and hyperlinks
- Flatten annotations (excludes hyperlinks)