Compliant ANDA Submission Under Stringent Timelines

The client, a US-based leading specialty pharmaceutical manufacturing and Contract Development and Monitoring Organization (CDMO) approached Freyr to seek assistance in filing original Abbreviated New Drug Applications (ANDA) and submitting them to the US FDA.  The following are the challenges encountered while taking up this project.

  • Reviewing all study documents as per the US FDA’s PDF specifications.
  • Carrying out the validation process for documents while managing last-minute document changes.
  • Tracking versions of frequently changed documents for electronic Common Technical Document (eCTD) submissions.

Freyr’s Publishing & Submissions team was able to provide end-to-end publishing support to the client by reviewing the study documents and making the final ESG submissions. With zero errors and over 70% cost benefits, Freyr was able to meet the customer’s compliance and business requirements.

For a detailed understanding of how Freyr's Publishing & Submissions team was able to successfully submit the ANDA correspondence to the US FDA by meeting the Regulatory objectives in a compliant manner, download the proven case.

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