Discover how to streamline your FDA regulatory submissions over secure and efficient AS2 channels, with support for large files (VLF), enhanced progress tracking, and complete control of your pharmaceutical data.
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The FDA ESG (Electronic Submissions Gateway) is a secure portal that allows the electronic submission of regulatory information to the U.S. Food and Drug Administration (FDA).
It facilitates the submission of various types of regulatory information, including new drug applications (NDAs), abbreviated new drug applications (ANDAs), biologics license applications (BLAs), investigational new drug applications (INDs), and other submissions required by the FDA.
The FDA ESG system streamlines the submission process, reducing paperwork and the administrative burden for both the industry and the FDA. It provides a secure and standardized method for regulated industries to submit electronic regulatory information to the FDA, ensuring data integrity and confidentiality.
Regulatory submissions sent through the FDA ESG must comply with the FDA's electronic submission requirements and standards. The FDA ESG system plays a vital role in modernizing regulatory processes, and supporting the FDA’s efforts to improve efficiency, transparency, and data quality in the review and approval of medical products.
Regulatory information refers to the data, documents, and other materials required by regulatory agencies—such as the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA), or other similar bodies—to evaluate and regulate medical products and practices.
Regulatory information plays a critical role in the regulatory approval process, as regulatory agencies use this data to assess the benefits and risks of products and make informed decisions regarding their approval, marketing, and post-market surveillance. Compliance with regulatory requirements for submitting accurate, complete, and timely regulatory information is essential for obtaining and maintaining regulatory approval for products.
Food and pharmaceutical companies report mandatory and optional information related to various products to the FDA, to meet the regulatory and reporting requirements. These submissions may be about adverse events, pre-market and post-market regulatory information etc.
From 2015 to 2021, the total number of submissions more than doubled, from 3.1 million, to 7.3 million, while for the first 10 months of 2022 alone, the total submissions totalled 7.1 million. [Source]
Most of the submissions to the ESG were directed to the Center for Devices and Radiological Health (CDRH), followed by submissions to the Adverse Event Reporting System (AERS), Center for Biologics Evaluation and Research (CBER) and the Center for Drug Evaluation and Research (CDER).
Submissions to the CBER and CDER are required to use the Electronic Common Technical Document (eCTD) format, and they must be submitted via the FDA ESG. An AS2 Gateway-to-Gateway connection is recommended by the FDA for such transfers.
FDA has three methods of submitting electronically; Unified Submission Portal (USP), AS2 and API. The agency receives thousands of submissions via those portals on a daily basis.
A modern web portal designed for low-volume submitters. USP allows users to log in upon creating an account, digitally sign and submit, and view agency responses through a simple web interface.
A system-to-system connection to exchange submissions with the FDA. AS2 requires a Gateway software implementation on the submitter's end.
A modern RESTful API over HTTPS designed to automate submissions to ESG NextGen, featuring support for large files.
AS2 Gateway offers seamless integration with your existing systems, automated message tracking, and detailed audit logs, ensuring smooth and efficient electronic submissions to the FDA.
The AS2 Gateway is available for deployment on-premises on a customer's own servers or virtual machines or containerized environments (e.g. Linux, Windows, Docker etc). It can also be deployed onto virtual machines or containerized runtime environments on Amazon AWS, Microsoft Azure or Google GCP.
The on-premises version of the AS2 Gateway has support for extremely large submissions in the Gigabyte range, and also supports AS2 restart - where partial file transfers are resumed from the failure point again, to save network bandwidth and time - without restarting from the beginning.
It also includes the ability for the console to pick up such large files from shared drives within the customer’s own private network. This prevents a duplicate copy from being made, even within the internal network, and also allows different departments to prepare the submissions, and use the AS2 Gateway to be used to directly pick up and send the individual files, and even prepare the .tar.gz file expected by the FDA.
The AS2 Gateway allows the specification of an Application ID and a Sequence number to generate the required .tar.gz file, using the proper GNU format file and path names, making sure that the submission can be successfully processed by the FDA. While the FDA uses the .tar.gz format with the specific folder structure and file names, the EMA uses a .zip file format without any specific required folder structure.
The support for the creation of custom 'Profiles' in the AS2 Gateway allows sending profiles to be created to include specific headers for submissions to the FDA, Health Canada (HC) and the European Medicines Agency (EMA) etc, so that the correct preset 'Profile' can be selected when making a submission, reducing the manual effort required, and the chances for errors.
Auto-detect and record acknowledgements from the FDA as ACK 2, ACK 3 etc, for efficient tracking, auditing and troubleshooting of each submission.
We have done it many times, for small, medium and some of the world’s largest pharmaceutical companies.
They can support millions of AS2 transmissions per day, and can move very large files tens of gigabytes in size.
ComplianceQuest required an AS2 communications gateway to exchange regulatory submissions with the FDA on behalf of its customers. A stable solution capable of submitting large files was a requirement.
"They understand the underlying technology and continue to provide great support. We look forward to expanding our offerings using AS2 Gateway solution."
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