Lifecycle Management (Variation) Submissions in the eCTD Format to the GCC

This UK-based client was a leading company in oral pharmaceuticals and was looking for Regulatory support in filing (variation) submissions in the eCTD format to the GCC. The project came with several challenges like tracking versions of frequently changed documents and stringent timelines. Freyr validated the documents and ensured zero errors in the submission by using Agency-recommended tools and carrying out rigorous quality checks throughout the publishing cycle.

Explore how Freyr was able to meet all the deadlines set by the client and ensured zero defects in their submissions with effective resource management and tracking frequently changed documents. Download the proven case.

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