Master your DMF easily, quickly and with guaranteed compliance

cune-eCTD is build to help you submit DMFs. A very cost effective pricing and a super fast software set-up, let you start today. Our global support (guaranteed 1h response time) guarantees 100% eCTD compliance for your first submission.

DMF Software Drug Master File

Built for DMF

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Are you ready for your DMF in eCTD?

FDA Deadline for Paper Submissions

Checklist: The Road To DMF ReadinessButton download ectd 5 crucial steps to your first DMF in eCTD

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!

Unlimited submissions

Unbeatable when 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

Selected Customer References – eCTD has never been easier

lj\elrdyrjyp

We selected cune-eCTD because of the compliance guarantee... it gives us great peace of mind.

GermipheneRegulatory Affairs Manager

The fast support of Cunesoft is understanding in this industry. Moreover, we like the intuitive user interface very much.

MakrocareHead of Regulatory

We never thought that FDA compliance can be so easy and at the same time cost effective with an all in one annual fee.

AthenexRegulatory Specialist

Guaranteed 100% eCTD compliance

Be 100% eCTD compliant:

Use the Cunesoft guarantee for your first submission

Work with the right tool:

Use built in submission templates based on latest FDA/ICH requirements

Save money:

Make use of the cost control via an annual all inclusive subscription fee

Never be alone:

Ongoing eCTD support via a 1 hour guaranteed response time

Use state of the art software:

21CFR11 compliance via private SaaS (Software as a Service)

Training on using the ESG (Electronic Submission Gateway):

Speedy start-up, training and validation

Assistance in setting up your FDA Account:

Rely on Cunesoft experiance and work most efficient

Get the job done:

Automatically convert your registered DMF’s into the eCTD format

Work confidently:

No system installation needed – we maintain a validated environment for you

Depend on Cunesoft’s experience:

Support to prepare the required eCTD test submission

cune-eCTD track record

Compliant eCTD Submissions

100%

over

users

 

over

submissions

less than

3 weeks

 implementation time

less than

3 months

till return on invest

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
  • 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.

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

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

cune-eCTD and VERA

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 DMF 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