DDReg Pharma

Gulf Health Council file upload for biosimilar product

One of the top three biopharmaceutical companies approached DDReg to get the dossiers for their product submitted to the Gulf Health Council (GHC). The challenge was to publish and submit the large size files to the GHC portal (Taawon) while running against the time.
As the team finished the grueling job of publishing the sections of 2GB of data, another challenge was lurking in the horizon. The team realized that, in the GHC portal, the file size limit was 500MB only. Therefore, the portal did not accept the file size of 2 GB. Furthermore, the portal only allowed for 1 slot for submission per application. The challenge was to upload the file successfully, within the stringent time frame, to avoid the risk of submission rejection.
The object was to successfully submit the file onto the GHC portal while adhering to the stringent timelines
The publishing team at DDReg utilized all in-house tools to compartmentalize sections of the file into smaller ones, each of less than 500MB for a successful upload. Meanwhile, the core regulatory affairs team used their resources to connect the local representative in the region, who liaised with the GHC to communicate the issue and open an additional 3 slots to allow the entire file to be uploaded in sections. GHC portal team understood the problem and helped by opening & allowing the multiple slots.
The RA team were successfully able to upload the files on the portal while meeting the strict timelines.
As this was outside of DDReg’s scope of work, the biosimilar manufacturers were impressed by DDReg’s level of commitment and dedication to the task and felt they had surpassed the expectations. As a result, the trust between the manufacturer and DDReg was strengthened, and DDReg received more biosimilar projects from them.

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