Business Imperatives

The client needed support in filing a DMF application to the US FDA. Additionally, to manage and track all the frequent revisions provided by the client on an incremental basis.

Objectives

To support a China-based pharmaceutical company in successfully filing a comprehensive Drug Master File (DMF) application with the US FDA by ensuring compliance with Regulatory requirements.

Problem Statement

  • The client was facing challenges in the timely submission of the DMF application to the US FDA.
  • They encountered difficulties with managing document splitting per FDA file size and page count requirements.
  • Compiling complex MBR reports, and other reports was an additional challenge.

Freyr Solutions and Services

Freyr Solutions and Services

Freyr also provided a diverse set of services that included:​

  • A submission roadmap was created​.
  • Granular document-level publishing​ was completed.
  • Detailed tracker creation to track all the version changes made through the publishing cycle​.
  • A two-stage QC process, including a Rosetta view​ was implemented.
  • A delivery of 4 GB submission with zero validation issue was delivered.

Freyr successfully supported the China-based pharmaceutical company in filling Drug Master File (DMF) application with the US FDA within the timeline provided enduring full compliance with Regulatory requirements.

  • Freyr offered a 24 X7, follow-the-sun, global delivery model to address the aggressive timelines​
  • Maintained transparency throughout the process.​
  • Achieved a 70% increase in cost efficiency.
  • Played an important role in accelerating the approval process, enabling the client to move ahead of the competition​.