Freyr Supported Dutch-Based Biotechnology Company in the Preparation, Review, and Submission of USDMF to FDA

Business Imperatives

A Dutch-based biotechnology company required expert regulatory assistance to prepare, review, and submit a US Drug Master File (USDMF) in electronic Common Technical Document (eCTD) format to the USFDA. The scope included conducting a gap analysis, compiling necessary documents, and ensuring a timely submission to meet regulatory requirements.

Objectives

The objective was to provide comprehensive regulatory support to a Dutch-based biotechnology company in the preparation, review, and submission of a US Drug Master File (USDMF) in eCTD format to the USFDA.

Problem Statement

The client faced challenges in understanding USFDA requirements for DMF submission, leading to documentation gaps and potential compliance risks. Additionally, a lack of familiarity with eCTD formatting and submission processes posed a risk of delays in regulatory approval.

Freyr Solutions and Services

Freyr conducted a thorough assessment of the source documents and promptly identified missing or incomplete data. A detailed gap analysis report was shared with the client, offering strategic guidance to mitigate compliance gaps.
Freyr’s regulatory experts prepared Module 1, Module 2.3, and Module 3 in alignment with USFDA and excipient guidelines.
Client feedback was incorporated efficiently, with DMF updates being made and shared for review on the same day to ensure a smooth submission process.
The finalized DMF was successfully published in eCTD format and uploaded through the ESG gateway within the agreed timelines.

Benefits

The client received end-to-end regulatory support for the preparation, review, and submission of the USDMF.
The proactive approach enabled on-time completion, minimizing risks associated with regulatory non-compliance.
Gaps were identified and resolved within the required timeframe.
Optimization of resources and time ensured a smooth and efficient submission process.