##  [Preparation, and Submission of SPL](/index%2ephp/case-studies/preparation-and-submission-of-spl) 

- [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)

 

 ![Preparation, and Submission of SPL]()

An Italian multinational pharmaceutical company approached Freyr for preparation and submission of SPL to USDFA.

With the objective of obtaining FEI number for ITF and SA, the client also had limited understanding in this requirement and overall approach and wanted an expert in this domain. With Freyr’s Regulatory support the client received the best Regulatory support until FDA submission.

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