Lifecycle Management (Variation) Submissions in the eCTD Format

The client was a China-based nuclear medicine manufacturer and diagnostic products and services provider looking for Regulatory support in submitting variations for their existing products in the eCTD format. There were several challenges in working with global teams virtually to offer continued support and validate the previously submitted sequences by another vendor. With in-depth knowledge in the global Regulatory specifications, Freyr's team imported the previous sequences and created an ongoing lifecycle maintenance submissions system. With document level publishing and the best gap analysis tools, Freyr made the submissions in the eCTD format on time.

Do you wish to know how Freyr could make multiple variation submissions in the eCTD format for the client’s existing products without any errors and zero deficiency comments? Download the proven case.

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