Unbeatable when e.g. doing more than 5 DMF’s per year
Unlimited test submissions
Required due to mandatory validation checks
Unlimited free support
100% eCTD compliance guarantee via outstanding eCTD experts
Always be prepared for an FDA audit
Cunesoft offers a ready to use, pre-validated and highly secure cloud based regulatory compliance suite. Our software has been built to fulfil regulatory needs holistically and end to end. Our vision is to keep it as simple as possible while delivering compliance and fulfilling FDA 21CFR11, EU Annex 11, ICH, and GxP requirements.
With the most automated eCTD solution available, you will be ready to manage all of your submissions globally, migrate from paper to electronic submissions, and be guided by our built-in virtual trainer to help you through each step of the process.
The most modern eCTD solution available:
Benefit from cune-eCTD’s built-in compliance checking capabilities, verify your hyperlinks are working and publish incrementally to check your progress.
cune-eCTD includes a sophisticated hyperlink manager which ensures your PDF links are accurate and in place. No more worrying about broken links when you finalize your submission.
cune-eCTD’s included eCTD Viewer provides multiple standard views of your submission and also lets you create personal views:
Will you be ready to submit your Drug Master Files (DMFs) in the eCTD format by 5th of May 2018? Being ready means making sure your documents are properly prepared (bookmarked, OCR’d, proper orientation), you are able to create your baseline DMF submission as eCTD, and establishing your connection to the FDA via the Electronic Submissions Gateway (ESG). The DMF in eCTD format mandate applies to amendments, letters of authorization and annual reports… no exemptions, no waivers!
cune-eCTD is built for this purpose and manages DMFs quickly, easily and compliantly!
…guides first time users through each step of the software
…assists in getting documents stored in the correct folders
… helps to prepare an eCTD submission
… guides on compliance fulfillment throughout the entire regulatory workflow
…can do even more
Rainer Schwarz CEO Cunesoft