##  [Two Step Review Process for Accelerating DMF Submissions](/index%2Ephp/case-studies/two-step-review-process-for-accelerating-dmf-submissions) 

- [Medicinal Products](/index%2Ephp/case-studies-main-categories/medicinal-products)
- [Publishing and Submission](/index%2Ephp/case-studies-main-categories/publishing-and-submission)





[US FDA](/index%2Ephp/case-studies-heath-authority/us-fda)

 

 ![Two Step Review Process for Accelerating DMF Submissions]()

An India based pharmaceutical company was looking to file DMF application for its product to the USFDA. The challenge was to file the applications within a short timeline while meeting the ICH standards and requirements, as some of the documents were not in the required format. Freyr assisted the client by managing all the submissions with 100% accuracy.

Through this case study, decode how Freyr deployed its Two Step Review process and ensured high quality submissions.



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