Factorytalk: eCTD eSubmissions
We are the SE Asian partner for LORENZ, the leading e-regulatory solutions provider to 14 leading government agencies across the world including North America, Europe, and Asia, and the go-to choice for industry when creating and managing product submissions.
Factorytalk offer end-to-end sales, implementation, and support services for the LORENZ solutions. Including technical training's and on-site consulting . We have completed many implementations in the region, including a full scale agency project with the Thai FDA, who became the 1st country in ASEAN to implement the eCTD submission format.
We also offer an eCTD submissions service from our Bangkok offices, customers can book to come and create submissions with technical support on-hand.
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 the different packages available from us, providing for a range of budget and performance requirements.
Own the software