https://www.youtube.com/watch?v=43ngkc2Ejgw
Compliant. Fast. Successful.

cune-eCTD for CANADA

You look for an easy to use and well supported eCTD submission software for your Canadian submissions? From January 1st, 2018, such regulatory activity types as NDS, SNDS, ANDS and SANDS as well as all additional information and subsequent regulatory activities/transactions for human drugs, must be filed in eCTD format. With cune-eCTD you create new or import existing electronic submissions with ease. Prepare and compile eCTD’s, NeeS, VNeeS, and paper CTD’s all in one place. This master piece of regulatory compliance software guarantees your success.

eCTD submission software

Unique eCTD Submission Software Benefits

At Cunesoft, Your Investment In Our Solution Equals Our Investment In Your Success!

Unlimited Submissions

Unbeatable when e.g. doing more than submissions per year

Unlimited Countries

Submit your e.g. INDs, variations, anual reports, MAs or DMFs worldwide

Outstanding Support

We promise you a 100% eCTD compliance guarantee

 

Fully Validated

Always be prepared for an FDA audit

Our Secret To Your Success

We Have Found That Over 70% Of Our Support Calls Are NOT Related To The Technology Itself…

  • 20/5 support availability

  • 1h guaranteed response time

  • Technical support services

  • Regulatory support services

  • Adhoc user training

  • eCTD Compliance Guarantee

…they are almost always about the questions starting with: How? What? Why? or Where?

We understand your needs and created an environment with outstanding and unique regulatory support – we will give you live training via Internet, we will always answer to your inquiry. Just call or write our support as often as needed! And most important – we help you not only with technical questions, but with the overall processes in addition to how to use cune-eCTD. With our eCTD submission software we guarantee your eCTD compliance!

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Like Nothing You’ve Seen Before

A Picture Is Worth A Thousand Words… Watch Our Video

Check compliance

Verify if your hyperlinks are working and publish incrementally to check your progress. Use the swift navigation with autocompile function, easily accessible from anywhere. The environment is hosted, managed and validated.

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.

All 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 (eSubmissions), and be guided by our built-in virtual trainer to help you through each step of the process.

eCTD viewer

Open and view eCTD, NeeS and other dossier fromats from anywhere. Of course, you can invite internal and external team members and share your dossier.

Meet Our Management Team

 

Deep Knowledge Of The Life Science Industry And Excellent Regulatory Understanding Helps Us Deliver Regulatory Peace Of Mind

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.

Contact us

Rainer Schwarz – CEO

Daniel Koppers – CTO

COO

Jim Nichols – COO

We Deliver Regulatory Peace Of Mind

We Are Driven By Our Desire To Be A Reliable Partner To Our Customers

  • 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
  • Automated NeeS to eCTD conversion
  • Made to submit marketing authorisation applications (MAAs)
  • Regulatory eCTD Training included
ASK FOR MORE INFO
eCTD submission software

From Old Into New

Use the Cunesoft expertise and automation workflows to transform existing submissions (e.g. NeeS or CTD) to eCTD

  • Step 1: You simply take your NeeS folder and create a ZIP file of your entire NeeS folder structure
  • Step 2: You upload that ZIP file to the Cunesoft RDMS module–> The system will then automatically create a product, create the folder structure from your NeeS and add all documents into the folders. Finally, a one click bulk publish then makes all your documents publishing ready.
  • Step 3: You add the meta data for the product (Substances, Substance Manufacturer, Product Manufacturer, Excipients, Indications, Studies if applicable)
  • Step 4: You create a new submission and cune-eCTD automatically creates the correct eCTD for your NeeS as Sequence 0000
  • Step 5: You compile the eCTD sequence for this submission, publish and submit it via the CESP

Become A Member Of The Cunesoft Family

Over 500 Active Users Love Our Compliance Software Tools.

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% Compliance with our eCTD submission software

This Promise Is Unique.

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:

GxP aligned and fully validated

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

Yes, Looks Are Important!

Display The eCTD Tree As You Wish With An Outstanding Tool – Meet Our eCTD-Viewer

1
The Delta View shows all of the differences between specific submission sequences. You can choose a start and an end sequence.
2
The Sequence View shows all operations of all sequences in different trees.
3
The Cumulative View shows all operations of all sequences in one tree.
4
This view allows the user to hide and unhide folders in an easy way. To hide folders, unselect the checkbox next to the folder to be hidden. Unselecting a parent folder will automatically unselect all children.
Our eCTD submission software – cune-eCTD includes eCTD viewer which 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

Selected Customer Reference

About Athenex

Based in USA and China, Athenex is a leading manufacturer of APIs and Chemicals, with state-of-the-art and regulatory approved cGMP facilities and R&D laboratories in China.

ectd vendor

How satisfied are you with cune-eCTD?

  1. We have been very happy with the regulatory eCTD submission software – cune-eCTD.
  2. Their system is great, especially the cloud based model and all the functionality/features of the submission software.
  3. Their customer support is remarkable, and when we have run into the inevitable complications with electronic filing, Cunesoft has supported us day or night to make sure that all of our filings were on time and in order.
  4. We are much more than satisfied with the combination of excellent product and excellent customer service provided by Cunesoft

Reasons for choosing Cunesoft

  1. Excellent value for the money versus traditional eCTD software vendors.
  2. All the features that we need.
  3. Similar features to competitors, but much more cost competitive.
  4. Subscription license model with multiple site access.
  5. Cloud based system perfectly supports the globally distributed Regulatory Affairs team.
  6. We can securely view our regulatory submissions from anywhere in the world.
  7. Recommended by an FDA consultant and another company who had a fantastic experience with the Cunesoft.

What We Have Achieved With cune-eCTD

Track Record

Compliant eCTD Submissions

100%

over

500

users

over

2000

submissions

less than

3 weeks

 implementation time

less than

3 months

until return on investment

Meet Your Build-in Assistant 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 
guides first time users through each step of the eCTD submission 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.

Request a Free eCTD Submission Software Demo

Experience the Power of cune-eCTD in a Call with our eCTD-Experts

eCTD Health Canada – an overview

 

eCTD becomes more and more mandatory in different regions and for various submission types. Soon only the eCTD format will be accepted throughout the marketing authorisation of drugs. One of the regions announcing eCTD as a mandatory format to be used for drug applications is Health Canada.

1.      Mandatory use of the Electronic Common Technical Document (eCTD) format

eCTD becomes more and more mandatory in different regions and for various submission types. Soon only the eCTD format will be accepted throughout the marketing authorisation of drugs. One of the regions announcing eCTD as a mandatory format to be used for drug applications is Health Canada.

In July 2016, Health Canada has stated that as of January 1st, 2018, the following regulatory activity types, as well as all additional information and subsequent regulatory activities/transactions (as per section 1.3 of the Guidance Document Preparation of Drug Regulatory Activities in eCTD Format) for human drugs, must be filed in eCTD format:

  • New Drug Submission (NDS);
  • Supplement to a New Drug Submission (SNDS);
  • Abbreviated New Drug Submission (ANDS); and
  • Supplement to an Abbreviated New Drug Submission (SANDS).

Regulatory activities for the following are recommended, however, not mandatory for filing in eCTD format:

  • Master Files;
  • Clinical Trial Applications (eCTD CTA pilot only);
  • Drug Identification Number (DIN) Applications and Post-Authorization Division 1 Changes (PDC) for Human drugs.

Regulatory activities for the following currently remain out of scope for filing in eCTD format; they must be filed in “non-eCTD electronic-only”:

  • Medical Devices;
  • Veterinary Drugs.

When applicable, regulatory transactions must be sent via the Common Electronic Submissions Gateway (CESG).

2.      eCTD requirements

Having a look on the eCTD requirements, the content based requirements are not changing and will be the same as for paper CTD submissions. However, having a look on the electronical part of the eCTD format there are various requirements to be considered.

The figure hereafter shows an overview of how an eCTD in Canada should look like:

eCTD requirements

Source:https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/applications-submissions/guidance-documents/ectd/preparation-drug-submissions-electronic-common-technical-document.html

From a hierarchical perspective, the highest folder within a Canadian eCTD, the so called Top Level Folder, must contain the sequence number folder which will include all other folders and respective content.

For the Top Level Folder a naming convention was specified, which requires the name to match the Dossier Identifier number (e.g. e123456) obtained. This number, obtained from Health Canada, is a a unique identifier for a specific drug product and stays unique throughout the dossier/drug product lifecycle.

As shown in the picture above, the sequence number folder will include the regional m1 part, the m2-m5 subfolders (as required), and the eCTD related technical files as the util subfolder, the eCTD backbone file (index.xml), and the eCTD calculated checksum file (index-md5.txt).

The m1 folder must contain a ca folder which should contain all Module 1 specific files as well as the Canadian Module 1 Backbone file (ca-regional.xml). No other subfolders should be present in the m1 folder.

The structure of Modules 2 to 5 (m2-m5) can be retrieved from the ICH Electronic Common Technical Document SpecificationHealth Canada’s Guidance Document: Preparation of Drug Regulatory Activities in the Common Technical Document (CTD) Format.

The util folder contains the technical auxiliary files for an eCTD, the so-called DTD & Stylesheets. The DTD folderdeposits the structure for module 1 and module 2-5 (as required from the different regions and the ICH).

The Stylesheets are technically used to display xml files and make them readable within a browser. The xml backbone is used as a navigation file which actually represents a Table of Content of the submission, avoiding clicking through the deep structure of an eCTD. As an eCTD is somehow divided between m1 the regional part and m2 to m5 the ICH part, there are two xml backbones provided. The regional backbone (ca-regional.xml) located in module 1 to easily navigate through the regional specific content and a separate xml backbone file (index.xml) for easy navigation through m2 to m5.

Each first regulatory activity within a dossier, must always start with sequence number 0000. Every new information specific to this dossier, must be provided with a new sequence, always using a 4-digits sequence number incrementally (e.g. 0001). If for any reasons, a sequence has been technically rejected, the sequence number should be kept the same as the failed one and be resubmitted once the technical issues have been solved. Other than that, e.g as of content rejection, a new sequence should be provided using the next incremental number within a dossier.

3.      Canadian Module 1 Backbone

3.1  Envelope Information

The envelope information can be extracted out of the ca-regional.xml. The regional backbone as already mentioned, is not only used for easy navigation but is used also for extracting the submissions key data information as well as defined metadata at a glance. The required envelope information differs from region to region.

An overview of Health Canada’s envelope information is presented hereafter:

The <applicant> Element

This mandatory element contains the sponsor’s name, i.e. the company which is submitting this regulatory transaction.   Great care should be taken to ensure accuracy and consistency with this content.  For example, the values “My Company” or “My Company, Inc.” or “My Company, Inc” are all different which may cause difficulties or delays in the processing of the regulatory transaction.

The <product-name> Element

This mandatory element contains the drug name, i.e. the product which is being addressed in this application. Great care should be taken to ensure accuracy and consistency with this content.  For example, the values “My Product” or “My product” or “My Product” (note the double space!) are all different which may cause difficulties or delays in the processing of the regulatory transaction.

The <dossier-identifier> Element

This mandatory element contains the unique identifier assigned to this dossier by Health Canada. It must be in the format “e999999”, i.e. a lower case letter followed by six digits.  It is expected that the sponsor will acquire a valid dossier identifier from Health Canada before submitting the initial regulatory transaction.

The <dossier-type> Element

This mandatory element contains the type of dossier, i.e. from a simplistic perspective, whether it is a pharmaceutical or biologic regulatory activity. . The content of this element is taken from a list of values defined by Health Canada

The <regulatory-activity-type> Element

This mandatory element contains the type of the regulatory activity, i.e. from a simplistic perspective, what regulatory purpose this filing is addressing.. The content of this element is taken from a list of values defined by Health Canada

The <sequence-number> Element

This mandatory element contains a four-digit number which is the unique identifier for this sequence (regulatory transaction) inside the overall dossier. The schema ensures that the content is in the format “9999”, i.e. four digits. Internally at Health Canada further validation will be performed to ensure that the number is unique within the dossier and is greater than previously filed sequence.

The <sequence-description> Element

This mandatory element describes the sequence (regulatory transaction) based upon a series of possibilities.

The <related-sequence-number> Element

This optional element contains the four-digit sequence number of the first sequence in this regulatory activity. The schema ensures that the content is in the format “9999”, i.e. four digits.

Source:

https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/applications-submissions/guidance-documents/ectd/notice-creation-canadian-module-1-backbone-2012-health-canada-consultation-document.html

3.2 The xml structure of Module 1

The xml file of Module 1 contains two categories of elements:

  1. Heading elements which act as an electronic Table of Contents to organize the documents submitted in Module 1. However, there are additional heading elements called node-extensions which can be created at pre-defined sections within an eCTD structure in order to group documents.
  2. Leaf elements which describe one document along with additional information such as the defined metadata or the document related lifecycle information (new, replaced, delete, append). Each document is linked and can be retrieved easily.

Important to consider when filing an eCTD, is to place each document on the lowest level of the eCTD tree. No document is allowed to be added inside a heading element which contains sub-headings.

In addition, it should be mentioned that there will be a difference between the physical folder structure within an eCTD and the xml structure/headings shown in the xml backbone. The software vendor which is used to prepare and file eCTD’s, usually provides the respective headings shown as folders within the application sticking to the xml headings defined by Health Canada. After eCTD has been published, the heading structure will be shown in the xml backbone where else the physical folder structure will not represent the same folder hierarchy and might only contain files. This output complies to Health Canada’s eCTD specification.

4.      Technical Validation for eCTD formats submitted to Health Canada

Once an eCTD has been filed and published, the next item on the list should be the technical validation. Before sending an eCTD over to the authority it must be validated from a technical perspective. This step should not be skipped, as any technical invalidity would lead to a rejection. Make sure you have a reliable eCTD software vendor – Cunesoft in place and  that your eCTD submission complies to the technical requirements specified by the respective regional authority. Health Canada has also defined various test steps to be proofed when submitting an eCTD.

As of January 1st, 2017 the profile to be used for Canadian eCTD submissions is: CA eCTD – Profile 4.

Any warnings and errors should be corrected, and a valid test result must be present before sending it over to Health Canada.

5.      The Common Electronic Submissions Gateway became mandatory (CESG)

On January 1st, 2017, Health Canada has announced that the CESG will be mandatory for all regulatory transactions under 10GB in size (including first transactions) prepared in the eCTD format. Because most transactions fall within this size limit, sponsors are strongly advised to obtain CESG accounts as soon as possible.

Sponsors providing files greater than 10 GB should continue to use media. For detailed information on how to file using media, refer to Section 3.2 (ii) of the Guidance Document – Preparation of Regulatory Activities in eCTD Format.