##  [Pre-IND Meeting request and 505(b)(2) Submission](/index%2ephp/case-studies/pre-ind-meeting-request-and-505b2-submission) 

- [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)

 

 ![Pre-IND Meeting request and 505(b)(2) Submission]()

A US-based pharmaceutical CRO approached Freyr for pre-IND meeting support and 505 (b)(2) submissions towards FDA.

The sponsor’s limited knowledge in this domain made the process towards delayed phase. With Freyr’s optimized resource support and via expedited resources support, the submission was made in a timely manner with the necessary details required by the FDA.



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