##  [Successful Filing of LCM Grouped IND Submissions and NDA-Initial ANDA](/case-studies/successful-filing-of-lcm-grouped-ind-submissions-and-nda-initial-anda) 

- [Medicinal Products](/case-studies-main-categories/medicinal-products)
- [Publishing and Submission](/case-studies-main-categories/publishing-and-submission)





[US FDA](/case-studies-heath-authority/us-fda)

 

 ![Successful Filing of LCM Grouped IND Submissions and NDA-Initial ANDA]()

A US-based life sciences consulting company was looking for Regulatory support in the filing of LCM Grouped IND Submissions and NDA-Initial ANDA.

Freyr’s Publishing & Submissions (P&S) team has addressed various challenges, such as:

- Investigating the study documents and offering support in end-to-end publishing activities.
- Filing ad-hoc submissions to the US FDA.
- Managing applications for promotional labeling that contain additional pieces of advertising.

Additionally, the P&S team created a detailed tracker to guide the customer on the various track and version changes made in the documents during the publishing process.

To understand how Freyr's P&S team extended its support to the customer in meeting their business requirements, download the proven case.



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