##  [Submission of 505(b)2 New Drug Application](/index%2ephp/case-studies/submission-of-505b2-new-drug-application) 

- [Medicinal Products](/index%2ephp/case-studies-main-categories/medicinal-products)
- [Medical Writing](/index%2ephp/case-studies-main-categories/medical-writing)





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

 

 ![Submission of 505(b)2 New Drug Application]()

A US-based drug development biopharma company approached Freyr for Regulatory support in submitting a 505(b)2 New Drug Application to the United States Food and Drug Administration (US FDA). The client faced challenges in streamlining the process, meeting stringent timelines, and managing stakeholders effectively. Freyr’s support to the client encompassed planning, technical, and QC support to submit the NDA to the Health Authority effectively.



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