Business Imperatives

A USA-based biopharmaceutical company required regulatory support for the compilation and submission of product correspondence to maintain the active status of IND 064179. Freyr's expertise was sought to ensure compliance with USFDA regulations and meet the submission deadlines.

Objectives

To provide end-to-end regulatory assistance, ensuring accurate evaluation, timely response to the pre-termination letter, and maintaining the IND status as active.

Problem Statement

The client faced challenges in managing IND maintenance activities due to a lack of prior experience in regulatory submissions. Additionally, understanding and responding to the USFDA's pre-termination letter within the given timeline posed a significant challenge.

Freyr Solutions and Services

Freyr Solutions and Services

Freyr provided comprehensive regulatory support to address the client’s challenges. The key solutions included:

  • Evaluation of the Pre-Termination Letter: Conducted a thorough review and assessment of the letter from the USFDA.
  • Strategic Input: Delivered expert guidance and actionable recommendations to maintain the IND status.
  • Timely Submission: Prepared and submitted a detailed response to the pre-termination letter, ensuring compliance with the USFDA's requirements.
  • Regulatory Compliance: The client received tailored regulatory advice, ensuring the submission aligned with USFDA expectations.
  • On-Time Submission: Timely response minimized the risk of IND termination.
  • Strategic Support: Freyr’s inputs ensured the client's regulatory objectives were met efficiently.

Freyr’s regulatory expertise facilitated the successful submission of the product correspondence, maintaining the active status of IND 064179.