What is the Gateway?

The ESG is a portal that facilitates communication between the FDA and the pharmaceutical industry by providing a secure digital environment to submit regulatory documents for review, which operates on a similar principle to Fully-Verified’s KYC provider service.

The FDA Electronic Submissions Gateway is an Agency-wide solution for accepting electronic regulatory submissions and is the required method of transmission for eCTDs 10GB or less.

We are certified ESG Production provider.

Plan ahead for first-time submissions via the Gateway

Gaining access to the ESG is a multistep process that’s too important to rush. Based on our experience, we’d recommend setting up your account at least 2 months before the due date for your first electronic submission.

We specialize in eCTD submission, the new FDA registration paradigm.   We submit or update DMF and BPF.

Our ESG eCTD FDA Production was certified and validated by FDA.   If you have any question or concerns, please contact us at jsc@fdaconsultantnusagent.com

 

The US Food and Drug Administration (FDA) is giving manufacturers an additional year before requiring master files to be submitted in electronic common technical document (eCTD) format.

In a revised guidance released in 2017, FDA says it is delaying the requirement for drug master files (DMF) and biological product files (BPF) to be submitted in eCTD format until 5 May 2018.

However, FDA is extending the date to comply with the requirement for master files to 5 May 2018 in response to concerns that some companies might not be able to meet the rapidly approaching deadlines.

“FDA has determined, in response to industry comments and internal review that there have been challenges with submission of master files in eCTD format, and eCTD uptake data for master files in particular indicated that adhering to the May 5, 2017 date could have led to high rejection rates of master files and thus slower FDA review processes,” FDA writes.

If you have any question or concerns, please contact us at jsc@fdaconsultantnusagent.com.  We specialize eCTD for DMF and BPF for either update or new submission.