##  [Compilation, Evaluation, and Successful Submission of IR to the USFDA](/index%2ephp/case-studies/compilation-evaluation-and-successful-submission-of-ir-to-the-usfda) 

- [Medicinal Products](/index%2ephp/case-studies-main-categories/medicinal-products)
- [Regulatory Affairs](/index%2ephp/case-studies-main-categories/regulatory-affairs)





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

 

 ![Compilation, Evaluation, and Successful Submission of IR to the USFDA]()

A US-based, leading generics pharma wholesale & distributing company was looking for Regulatory support in the compilation, evaluation, and submission of IR to the USFDA. The project presented several challenges such as stringent deadlines, identifying the gaps in the documents sent by the customer, and collaborating with other stakeholders for faster TAT. Freyr’s team addressed all the challenges by reviewing the documents and the CBE 30 thoroughly. The customer was able to uphold product compliance and continuity in the US market.

Know more about how Freyr helped the customer meet their business requirements in defined timelines and ensured the successful submission of IR to the USFDA. Download the proven case.



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