##  [Submission Strategy, Preparation, and Submission of Pre-NDA Meeting Request](/index%2ephp/case-studies/submission-strategy-preparation-and-submission-of-pre-nda-meeting-request) 

- [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)

 

 ![Submission Strategy, Preparation, and Submission of Pre-NDA Meeting Request ]()

An Italian multinational pharmaceutical company approached Freyr its strategic planning concerning pre-NDA meeting request.

The client does not have a prior experience with this request and wanted a Regulatory strategy expert like Freyr to streamline its submission towards Health Authority.

With Freyr’s Regulatory affairs and operations’ team support, the client received a complete understanding in this regard with timely submission to FDA.

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