Qualification & Validation
Qualification & Validation
Quality Assurance
Quality Assurance
Regulatory Affairs
Regulatory Affairs
Clinical
Clinical
Lab Services
Lab Services
Vigilance
Vigilance
Software Solutions & Services
Software Solutions & Services
Tox green
Toxicology
Pharma (2)
Pharma & Biotech
Medical Devices (2)
Medical devices
IVD (2)
In vitro diagnostics
Search QbD Group
  • There are no suggestions because the search field is empty.
eCTD Publishing - Regulatory Affairs - QbD Group

eCTD Publishing

The skills needed to confidently compile electronic submissions can take years of training, industry immersion and regulatory study. Full or partial outsourcing to a proven eCTD partner gives your organization the flexibility to allocate resources to other projects. 
 
QbD Group is your competent partner for electronic submissions. 

Read more

 

The electronic Common Technical Document (eCTD)

Based on the content of the Common Technical Document (CTD) format, the Electronic Common Technical Document (eCTD) transfers regulatory information from industry to agency in electronic form. The technical components consist of a high level folder structure, XML based metadata, document type definitions (DTDs) and stylesheets. 

All types of regulatory information can be submitted in electronic format, including new applications, variations and renewals for national, mutual recognition, decentralised and centralised procedures. 

How to create eCDTs

How to create eCTDs

The files in an eCTD should be organized according to the version 3.2 of the ICH eCTD specifications and the current version of the EU Module 1 specifications. The eCTD consists of (mostly) PDF leaf documents, stored in the eCTD directory structure, crucially accessed through the XML backbone (index.xml) and with the files integrity guaranteed by the MD5 Checksum.

 

In order to use eCTD, marketing authorization holders need to invest in appropriate software and maintain support systems. 

How we support you
The-key-role-of-Regulatory-Affairs-from-drug-development-to-commercialization-900x506

How we support you

Handling eCTD submissions requires precision, expertise, and the right tools.

At QbD Group, we provide comprehensive support to ensure your electronic submissions are efficient, compliant, and meet regulatory standards.

 

We help you with:

Validate and select eCTD software

Compile accurate & compliant eCTDs

Prepare and submit electronic applications

Provide ongoing eCTD maintenance and support

portrait image - website (25)

Why partner with QbD Group?

EXCEPTIONAL RA SERVICES THAT MEET YOUR NEEDS​ 

Choosing QbD Group means partnering with a trusted leader in Regulatory Affairs. With over a decade of expertise, we provide tailored support across the entire product lifecycle, ensuring seamless compliance and customer satisfaction on a global scale.

  • 10+ years of experience: benefit from our team of highly qualified consultants. ​
  • Full life cycle support: full support from pre- to the post-marketing phase.​
  • Global presence​: QbD Group operates globally, at QbD Austria with a special focus on Europe (EU) and China.​
  • Customer satisfaction​: constant evaluation, transparency and clear objectives.​ 
Get in touch
doc-mask

Related content

preview_image
Whitepaper

Regulatory Affairs for Pharma and Biotech

In this flyer, you will learn more about the regulatory services QbD Group provides for the pharmaceutical and biotechnology industries.
Read more
preview_image
Whitepaper

Clinical Evaluation for Medical Devices under MDR

This whitepaper will guide you through crucial regulatory documents pertaining to the clinical evaluation process of your medical device. Download now!
Read more
preview_image
Whitepaper

IVDR extension: what does this mean for you?

In this whitepaper, you will learn the impact of the IVDR transition extension and receive tips and strategies to navigate these regulatory changes.
Read more
preview_image
Webinar

Drug-Device Combination Products and Article 117

Explore the regulatory complexities of Drug-Device Combination Products. Learn about Article 117 requirements, Notified Body Opinions, and more.
Read more
Discover all

 

contact-mail

Get in touch

Ready to streamline your electronic submissions with a trusted eCTD partner?

Our experts are here to guide you through every step, from software selection to fully compliant submissions. Let us help you ensure accuracy and efficiency in your regulatory processes.














RA_Get in touch