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THE FIRST eCTD IN ASEAN

Factorytalk Co., Ltd. together with their software partner LORENZ has completed a pilot project for the Thai Food and Drug Administration (FDA) to implement the first eCTD in ASEAN for electronic applications of drug product registrations.
The project included providing a complete set of software and services to re-engineer and automate the existing procedures to receive, review and process applications and has enabled totally electronic submissions using international standards with a leading global solution. The project was initiated by the Bureau of Drug Control as part of its goal to be fully paperless and now the pilot project is complete.