Overview

G&L Healthcare Advisors was engaged by a mid-tier US pharmaceutical company preparing to submit a New Drug Application (NDA) for a rare kidney disorder. 

The client required urgent medical writing quality control (QC) support to finalize and review critical documents for their submission to the U.S Food and drug Administration (FDA) within tight deadlines.

Challenges

The client faced several significant challenges in the NDA submission process:
Tight NDA filing deadline: The client was facing a rate-limiting pivotal study and needed immediate support to finalize and QC Module 2 clinical summaries to meet the NDA filing date.
Limited internal resources: The client required additional medical writers to assist with both the editorial review and QC of Module 2 documents within a short timeframe.

G&L’s Approach and Solution

G&L provided rapid assistance to help the client meet their tight regulatory deadlines. Key activities included:
Onboarding and team integration: G&L onboarded two medical writers (one senior, one junior) within two days to assist with the editorial review and QC of Module 2 clinical summaries and overviews.
Senior medical writer leadership: The senior writer led the document review and authored the Module 2.5 clinical summary, ensuring high-quality submissions.
Junior medical writer support: Under the direction of the senior writer, the junior writer performed document formatting, content QC, and data integrity checks to verify the Module 2 data transfer from Clinical Study Report (CSR) source files.

Impact and Outcomes

As a result of G&L’s support:
Successful NDA filing: The client successfully met their scheduled NDA filing date, with all documents finalized and QC’d.
Ongoing support for IRs: G&L was subsequently engaged to assist with Information Requests (IRs) during the FDA’s review of the NDA.
Path to NDA approval: The client remains on track to obtain NDA approval for their product.