eCTD Insights | Sumble

What is eCTD?

The electronic Common Technical Document (eCTD) is a standard format for submitting information to regulatory authorities like the FDA, EMA, and Health Canada for drug applications, including new drug applications (NDAs), abbreviated new drug applications (ANDAs), and biologics license applications (BLAs). It is used to organize and submit documents electronically, replacing paper-based submissions. The eCTD provides a structured, searchable, and standardized way to present data, facilitating review and assessment by regulatory agencies.

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What other technologies are related to eCTD?

eCTD Competitor Technologies

docuBridge

docuBridge is a software solution used for managing and submitting electronic regulatory submissions, directly competing with eCTD submission software.

mentioned alongside eCTD in 26% (62) of relevant job posts

Veeva Vault

Veeva Vault is a cloud-based platform that includes capabilities for managing regulatory submissions, thereby competing directly with eCTD submission management software.

mentioned alongside eCTD in 1% (53) of relevant job posts

eCTD Complementary Technologies

define.xml

define.xml is a standard for describing the structure and content of clinical trial data, and is complementary as it provides metadata for eCTD submissions.

mentioned alongside eCTD in 7% (70) of relevant job posts

CDISC

CDISC standards are used to standardize clinical trial data, making it easier to submit and review in eCTD format, which are therefore strongly complementary.

mentioned alongside eCTD in 2% (53) of relevant job posts

EDMS

An Electronic Document Management System (EDMS) is used to manage the documents that are included in an eCTD submission. Although generic, it's still complementary.

mentioned alongside eCTD in 1% (51) of relevant job posts