Confidence and compliance with your eCTD submissions
Publish regulatory compliant PDF submissions for various Health Authorities with great efficiency
GlobalSubmit PUBLISH enables you to create health authority compliant eCTD submissions. The software enables you to:
- Identify and correct validation errors in real-time with Live Validation
- Automate the creation of hyperlinks and bookmarks with Link
- Efficiently confirm bookmark and hyperlink destinations with CrossCheck
Certara’s GlobalSubmit eCTD software has processed over 1.5 million regulatory submissions.
- 21 CFR Part 11 compliant
- Validation provided for you with each release
- Training provided by regulatory experts
- Seamless integration with industry leading electronic document management systems (eDMS)
- Supports investigational and marketing application submissions (IND, NDA, ANDA, sNDA, BLA, MAA, DMF, ASMF, NDS and more)
- Compile eCTD submissions for various health authorities including:
- US FDA
- European Medicines Agency (EMA)
- Health Canada
- Swissmedic
- Australia’s Therapeutic Goods Administration (TGA)
- Japan’s Pharmaceuticals and Medical Devices Agency (PMDA)
Save time with the most efficient publishing tool in the world
Efficiency in publishing your eCTD submissions is crucial as your regulatory department races to meet deadlines and deliver treatments to patients. Whether you are an experienced publisher or brand new, promptly publishing eCTD submissions can be challenging.
With 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, which significantly reduces your timelines.
With the ability to identify and correct your errors in real-time with Live Validation, auto process regulatory compliant PDF documents, and accelerate your quality control (QC) process, GlobalSubmit PUBLISH streamlines your eCTD publishing workflows.
Reduce risk of technical rejection with Live Validation
Certara’s GlobalSubmit Live Validation assesses the technical validity of regulatory submissions and eliminates the risk of technical rejection. Live Validation checks for over 200 error conditions of varying severity levels, including 40+ PDF checks. In fact, Live Validation has processed over 1.5 million regulatory submissions.
Auto process regulatory compliant PDFs
GlobalSubmit PUBLISH eliminates tens of thousands of routine, manual 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 page
- Embed all fonts
- Inherit zoom for bookmarks and hyperlinks
- Flatten annotations (excludes hyperlinks)
Reduce your QC process of eCTD submissions from hours to minutes
With CrossCheck, reduce your QC process of eCTD submissions from hours to minutes! 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 in real time. This innovation expedites an activity that accounts for 40% of your working time when building your eCTD submissions.
Here to help as you need us
Rest assured that if you have a large submission due with limited resources or just need a hand from time to time while internal resources are out of the office, Certara’s Regulatory Operations team can jump right in. Our submission management services include submission leadership, program management and planning, due diligence and readiness preparation, submission compilation, and eCTD publishing. We support applications to all major health agencies, including the FDA, Europe’s EMA, Health Canada, Japan’s PMDA, and China’s NMPA.