A leading India based Pharmaceutical Company was looking for an electronic system to compile, validate, publish, track, and manage the dossiers in eCTD format for Thailand. The project posed several challenges, including the need for seamless management of the entire eCTD lifecycle, ensuring compliance with regulatory standards, and meeting strict review timelines. To address these challenges, Freyr Digital provided round-the-clock support to the client and employed a delivery model tailored to the specific needs of the Thailand region. Consequently, the documents were converted efficiently within the prescribed timeframe, with meticulous attention given to every aspect of the submission process.

To gain insights into how Freyr Digital accomplished the feat of managing stringent timelines while attaining regulatory compliance for ThaiFDA submission, as well as their comprehensive support throughout the end-to-end submission and publishing processes, refer to the downloadable verified case study.