Factorytalk: eSubmissions

Factorytalk provides end-to-end software and services for delivering high quality submissions that the Thai FDA relies on. In 2014 the agency went live with the LORENZ docuBridge solution to review and validate all eCTD submissions and in 2017 ONLY electronic submissions will be accepted.

What is eCTD?

An eCTD is the electronic submission of registration files that are organized according to the version 3.2 of the ICH eCTD specifications and the current version of the TH Module 1 (M1) specifications. In other words, an eCTD is the submission of primarily 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. The eCTD as implemented by the Thai FDA brings the agency to the same technical standard as the leading international agencies and enables improvements in the quality and the time for review.

What is the technical requirement?

To submit an eCTD, applicants are free to use any appropriate software to compile and publish eCTD submissions. Below is a selection of different packages available for every budget and performance requirement.

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