Business Imperatives

A biotechnology company required assistance in compiling, reviewing, and submitting an Information Request (IR) response for their Antibody Conjugate US Drug Master File (USDMF) to the FDA. The project aimed to ensure compliance with regulatory requirements and meet the tight submission deadline.

Objectives

The objective was to ensure a timely and compliant response to the FDA’s Information Request (IR) for the Antibody Conjugate USDMF by leveraging regulatory expertise, optimizing resources, and aligning with FDA expectations to facilitate a successful submission.

Problem Statement

The client faced a short timeline for preparing the IR response and had limited internal resources with experience in addressing FDA queries. This created a risk of non-compliance and potential delays in submission.

Freyr Solutions and Services

Freyr Solutions and Services
  • Freyr leveraged the existing source data and worked closely with the client to prepare the response and Module 1 documents within a short timeframe.
  • Upon receiving client confirmation, Freyr finalized the response and collaborated with the publishing team for submission.
  • The published response package was shared with the client for final confirmation.
  • After approval, Freyr successfully published the DMF response in eCTD format and uploaded it through the CESG gateway, ensuring timely submission.
  • A comprehensive strategy and response to FDA queries were prepared within tight timelines.
  • The response aligned with current FDA expectations and regulatory requirements.
  • The DMF submission was completed on time and successfully submitted to the health authority.
  • The gap was identified and resolved within the designated time frame.
  • Resources and time were optimized, leading to increased efficiency and cost savings.