Electronic Submissions Gateway (ESG) is a transfer portal for electronic submissions of documents for review to the Food and Drug Administration (FDA) in a digitally secure environment. It is highly scalable and is extremely safe for the exchange of pre-market and post market Regulatory information between FDA and organizations submitting the information. It is a single point of entry for electronic submissions. ESG receives submissions, acknowledges receipt and directs them to the FDA office. It supports electronic Regulatory submissions, by making eCTD a standard, for the Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER). Apart from this, ESG also supports the receipt of reports and attachments for many other FDA offices.
Methods of submission through ESG
- WebTrader (WT) – WT portal allows low volume submissions. With a user-friendly interface. WT helps users to log in, digitally sign, make submissions, and view responses.
- AS2 – This method builds a system-to-system connection between FDA and companies to exchange submission documents. AS2 requires the installation of a gateway software at both the user ends.
Steps to set up an ESG account
As the process of submission is time taking, it is advised to set up an ESG account at least two-month prior to the submissions. Following steps are required to be followed to set up an ESG account:
- Acquiring a digital certificate
- Submitting a non-repudiation letter
- Applying for a test account
- Following FDA instructions to set up the system
- Load compliant submissions post building the connectivity
- Sending test submissions
- Waiting for FDA's approval post which the account is ready to be used
Benefits of ESG
- Hassle-free and inexpensive mode of submitting documents
- Automatically directs the documents to the required FDA officer/center
- Provides notifications to the concerned officials of the FDA as well as acknowledges sender with receipts
- Saves time
Submissions are a crucial part of any product life cycle and ESG is here to make it easier. Still unsure how to go for submissions through ESG? To know more, contact our experts at email@example.com.