##  [Successful NDA - Medical Device Submission in Reduced Delivery Time frame (from 50 days to 16 Days)](/case-studies/successful-nda-medical-device-submission-in-reduced-delivery-time-frame-from-50-days-to-16-days) 

- [Medicinal Products](/case-studies-main-categories/medicinal-products)
- [Publishing and Submission](/case-studies-main-categories/publishing-and-submission)





[US FDA](/case-studies-heath-authority/us-fda)

 

 ![Successful NDA - Medical Device Submission in Reduced Delivery Time frame (from 50 days to 16 Days)]()

A global top 20, Pharmaceutical company was looking for comprehensive publishing and submission solution for multiple NDAs, INDs, CSRs, and life cycle management applications. Some of the bottlenecks from client side included several rounds of republishing, style templates that are existing but not followed while document preparation which led to delay in approvals etc.

Read this report to decode how Freyr established a PMO and completed first successful NDA-medical device submission within 16 days.



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