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Regulatory Operations

Thank you Freyr for responding to our extremely pressing issue regarding SPL submissions. Though the requirement was on a short turnaround time failing which the application to the FDA had to be cancelled. You guys have worked it out without compromising. We are extremely happy to see your rapid response in sharing the package to FDA. The entire Freyr team has to be congratulated on being able to provide an important service in a very short period of time. Again, thank you for the unbelievable response to our pressing request.

A huge thanks to Freyr Digital for the excellent support in turning around 100 (approx..) lit references, which were needed in a short period in support of a New Drug Application (NDA) submission. Really appreciate their dedication and hard work in making this possible. This is a critical submission for us and therefore I wanted to take the time to let you know that the submission team recognize your contribution and are extremely grateful for your support not only for these but also for the hundreds of reports, which you’ve republished to make submission-ready for this major submission.

The SPLs looked good. And the response to one of our queries to handle combining/de-listing was also great

Thank you so much. We appreciate the work spirit shown by Freyr to get things done whenever required on priority basis.