##  [Development of USPI and Labeling Documents for an NDA](/index%2ephp/case-studies/development-of-uspi-and-labeling-documents-for-an-nda) 

- [Medicinal Products](/index%2ephp/case-studies-main-categories/medicinal-products)
- [Labeling](/index%2ephp/case-studies-main-categories/labeling)





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

 

 ![Development of USPI and Labeling Documents for an NDA]()

A global leader in innovating pathways for 505 B2 approvals based in the USA was looking for a Regulatory expert to develop USPI labeling documents for 505 B2 NDA approval. The client had various bottlenecks due to the absence of first-hand clinical and non-clinical data and outdated labeling content of the RLD. By performing the fast-track assessment with multiple level quality checks, Freyr enabled the client to achieve a first-time-right document that resulted in significant savings in terms of time and cost.

Learn how Freyr helped the client strengthen their labeling functions and ensured submission-ready documents while meeting the defined timelines.



Fill the form below to download the Case Study

 You must have JavaScript enabled to use this form.

  

  

  

 How did you hear about us?Search EngineE-mail CampaignGoogle AdsSocial MediaLink from another websiteColleague’s RecommendationNewsletterPrinted BrochureOther 

  

 

 

     I have read the [privacy policy](https://www.freyrsolutions.com/privacy-policy) 



 

 Submitted Page URL  

 Website URL  

 Content Type  

 Form Name