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.

Labmark is your competent partner for electronic submissions.

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 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 East Africa 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.

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How we support you

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

At labmark, 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

Why partner with labmark ?

EXCEPTIONAL RA SERVICES THAT MEET YOUR NEEDS

Choosing labmark 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: Labmark Group operates globally, at Labmark Tanzania with a special focus on Tanzania and East Africa .
Customer satisfaction: constant evaluation, transparency and clear objectives.