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.