Compliant. Fast. eCTD.

Create new or import existing electronic submissions. Prepare and compile eCTD's, NeeS, VNeeS, and paper CTD's all in one place.

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Are you ready for your DMF in eCTD?

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All regions

Check compliance

Manage hyperlinks

eCTD viewer

Unlimited submissions

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

 

Fully validated

Always be prepared for an FDA audit

 

Who we are

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.

 

All eCTD Regions

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:

  • Guaranteed ICH Compliance – no maintenance needed
  • Compile eCTD’s for US, CAN, EU, CH, SA, TH, JP, AUS, SAUD
  • Designed for all submission typs such as variations, renewals, PSURs, ASMFs
  • Smooth transition from paper to electronic submission
  • Made to submit marketing authorisation applications (MAAs)
  • Regulatory eCTD Training included
Click here to watch the powerful learning tool and meet VERA...
eCTD-Overview
eCTD-Overview
  • 21 CFR Part 11 compliant

  • ICH eCTD Specification V3.2.2

  • GxP aligned and fully validated

eCTD-Create-New-Submission-with-Regions-Overview

eCTD Compliance Check

Benefit from cune-eCTD’s built-in compliance checking capabilities, verify your hyperlinks are working and publish incrementally to check your progress.

  • Swift navigation with autocompile function
  • Easily accessible from anywhere
  • Hosted, managed and validated environment

Manage Hyperlinks

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.

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eCTD Viewer

cune-eCTD’s included eCTD Viewer provides multiple standard views of your submission and also lets you create personal views:

  • Current View
  • Sequence View
  • Delta View
  • Cumulative View
  • Personal Views
  • Current View

Submit your Drug Master files (DMF) with cune-eCTD

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!

cune-eCTD and V.E.R.A.

Virtual Electronic Regulatory Assistant

Vera …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 

VERA…

…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

Learn by doing

“This leads to a new dimension of user experience and work efficiency.”

Rainer Schwarz CEO Cunesoft

Contact us and enjoy a FREE Demo

Request a Demo                                          Trial Version