What is electronic submission Gateway?

The FDA Electronic Submissions Gateway (ESG) is the central transmission point for sending information electronically to FDA. The ESG does not open or review submissions. It receives submissions, acknowledges receipt, routes them to the proper FDA center or office, and notifies that center or office of delivery.

Where can I get a FDA submission?

FDA does not recommend specific tool vendors, however, they can be located via internet search. Questions and general information regarding the preparation of submissions in electronic format may be directed to CDER at [email protected] or CBER at [email protected].

What is FDA WebTrader?

WebTrader: WebTrader is a web-based interface used to send documents and receive receipts and acknowledgments from the FDA. System-to-system communication (often referred to as an AS2 Account) provides an automated connection to the FDA for submissions, receipts and acknowledgments.

How do I submit documents to the FDA?

How do I provide the documents to FDA?

1. Upload the documents into Import Trade Auxiliary Communication System (ITACS).
2. Use the find an import office contact page to determine your local import division email address, postal address, and/or FAX number to submit documents outside of ITACS.

What is needed for FDA submission?

An eCTD submission has five modules: region-specific information, summary documents, quality-related information, nonclinical study reports, and clinical study reports. When materials are submitted electronically, it is easier for FDA to review data, approve new drugs, and monitor drugs after they go on the market.

What is the FDA ESG?

The Food and Drug Administration (FDA) Electronic Submissions Gateway (ESG) is an Agency-wide solution for accepting electronic regulatory submissions. The FDA ESG enables the secure submission of premarket and postmarket regulatory information for review.

How do I create a WebTrader account?

Setting up a WebTrader Account Checklist

1. Send an email to [email protected] requesting a WebTrader test account.
2. Send a hard copy Letter of Non-Repudiation to the FDA.
3. Obtain a personal digital certificate from a CA or create one using our certificate generation tool .

What are regulatory submissions?

What are Regulatory Submissions? “A regulatory submission is a series of documents sent by a drug company to a health authority as evidence of compliance,” Koperniak says. “Laws and regulations influence many aspects of the drug development process.