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FDA Regulatory Submissions over AS2 to the ESG

The FDA (Food and Drug Administration) has a few details to adhere to when communicating with it over AS2 Protocol.
We have done it many times, for small, medium and some of the world’s largest pharmaceutical companies.

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Our solutions run on Amazon AWS, Microsoft Azure or Google GCP, and support on-premise deployment on servers, VMs or containers.
They can support millions of AS2 transmissions per day, and can move very large files tens of gigabytes in size.

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What is the
FDA ESG?

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 electronic 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 types of submissions required by the FDA.
The FDA ESG system helps streamline the submission process, reducing paperwork and administrative burden for both industry and the FDA. It provides a secure and standardized way 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 crucial role in the modernization of regulatory processes, supporting the FDA's efforts to enhance efficiency, transparency, and data quality in the review and approval of medical products.

What is Regulatory Information?

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.

These products particularly related to healthcare, pharmaceuticals, medical devices, biotechnology, food, and cosmetics.
Product Information
Details about the product, including its composition, formulation, manufacturing process, intended use, indications, contraindications, and dosage.
Clinical Data
Information from clinical trials and studies conducted to assess the safety and efficacy of the product. This may include study protocols, clinical trial results, adverse event reports, and pharmacovigilance data.
Quality Data
Data related to the quality control, manufacturing processes, and quality assurance measures implemented during the production of the product. This may include manufacturing records, batch records, stability data, and certificates of analysis.
Regulatory Submissions
Documents submitted to regulatory agencies for product approval, such as new drug applications (NDAs), biologics license applications (BLAs), premarket approval applications (PMAs), and marketing authorization applications (MAAs).
Labeling and Packaging Information
Information provided on product labels and packaging, including prescribing information, patient information leaflets, package inserts, and labeling for use in specific populations.
Safety and Risk Information
Data on the product's safety profile, including adverse event reports, risk assessments, and risk management plans.
Post-Market Surveillance Data
Information collected after the product is on the market to monitor its safety and effectiveness, including post-market studies, adverse event reporting, and product recalls.
Compliance Documentation
Documents demonstrating compliance with regulatory requirements, such as good manufacturing practices (GMP), good clinical practices (GCP), and good laboratory practices (GLP).

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.

Regulatory Submissions to the FDA Electronic Submissions Gateway (ESG)

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 till 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.

Methods of FDA Submissions

FDA has two methods of submitting electronically; WebTrader and AS2. The agency receives thousands of submissions via those portals on a daily basis.

WebTrader (WT)

A web portal designed for low volume submitters. WT allows users to login upon creating an account, digitally sign and submit, and view agency responses through a simple web interface.

AS2

A system-to-system connection to exchange submissions with FDA. AS2 requires a Gateway software implementation on the submitter's end.

How AS2 Gateway can meet your FDA regulatory submission needs

Multiple Deployment Options

The AS2 Gateway is available for deployment on-premise 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.

Extremely Large Submissions

The on-premise 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 customers own private network. This prevents a duplicate copy from being made, even within the internal network, and also allow 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.

Specifying of an Application ID and a Sequence number

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.

Custom Profiles

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.

Detect Acknowledgements

The AS2 Gateway also has the capability to detect acknowledgements from the FDA as ACK 2 and ACK 3, so that it is easier for debugging.

Get inspired with
Success Stories
ComplianceQuest
ComplianceQuest deploys AS2 Gateway to share regulatory submissions with the FDA

The AS2 Gateway solution was installed on-premises for development, test, validation and production environments. The solution was integrated with the ComplianceQuest systems using webhooks and the AS2 Gateway REST APIs. The solution has successfully automated customer submissions for past couple of years.

Read Case Study
"Aayu Technologies has been a fantastic partner. They understand the underlying technology and continue to provide great support. We look forward to expanding our offerings using AS2 Gateway solution."
Atulya Risal, COO / CTO
ComplianceQuest

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On-premise installable solution for AS2 file exchange.

AS2 Gateway Software: Trusted for FDA Regulatory Submissions.

Integrate with your internal systems
using SFTP, REST APIs and Webhooks, or direct file copy between shared directories.

Software is available for evaluation
Try before you buy. Contact Us for more details.

Flexible Deployment Options
Run seamlessly on Amazon AWS, Microsoft Azure, or Google GCP, and support on-premise deployment on servers, VMs, or containers.

Transactions Scalability
Support millions of AS2 transmissions per day.

Efficient File Handling
Capable of moving very large files, tens of gigabytes in size, with ease.

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