An Indian multinational pharmaceutical company reached out to Freyr to file BLA promotional labeling submission in eCTD. The submission was with the US FDA. Apart from working on large volumes of documents in a defined period, the major challenge was to track periodically amended documents and convert them into eCTD.

Read this case study to learn how Freyr assisted the client with accurate and timely BLA promotional labeling material eCTD submission to the US FDA.