FDA Gateway Transmission
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FDA Gateway Transmission

Secure, Reliable Submission Delivery

Overview

The FDA Electronic Submissions Gateway (ESG) is the mandatory portal for electronic submission to FDA. Gateway transmission requires proper technical setup, security credentials, and monitoring to ensure successful delivery. Our publishing team handles the complete gateway process—from pre-submission validation through acknowledgment receipt—ensuring your submission reaches FDA without technical issues.

Key Features

FDA ESG account management and credentials
Pre-transmission validation and final QC
Secure upload to FDA Gateway
Real-time transmission monitoring
Acknowledgment receipt and confirmation tracking
Issue resolution and retransmission if needed

Our Process

1

Pre-Submission Validation

We perform final technical validation to ensure the package meets all FDA gateway requirements.

2

Gateway Upload

We securely transmit your submission package to FDA through the Electronic Submissions Gateway.

3

Status Monitoring

We monitor the gateway for processing status and catch any issues immediately.

4

Confirmation

We provide you with FDA's acknowledgment and confirmation documentation for your records.

Project Complete & Deliverables Provided

Frequently Asked Questions

The ESG is FDA's secure electronic portal for receiving regulatory submissions. All eCTD submissions to FDA must go through the ESG. It provides secure transmission, validation, and acknowledgment of receipt. You can either set up your own ESG account or use a publishing partner like us who maintains ESG access.

Why Choose Us

  • Reliable, first-time-right gateway transmission
  • No need to maintain your own ESG infrastructure
  • Complete visibility into submission status
  • Expert handling of any gateway issues
  • Documented confirmation for your records

Get More Details

Request a personalized consultation and detailed information about this service.

Personalized consultation
Detailed service information
Custom timeline & proposal
Request Information

We'll respond within 24 hours

Ready to get started?

Contact our team to discuss your specific needs for FDA Gateway Transmission.

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What Our Clients Say

"We had a gateway issue at 11pm the night before our PDUFA date. Adelphi's publishing team stayed on it until 2am, identified a file corruption issue, fixed it, and successfully transmitted before deadline. That dedication saved our timeline."

Sarah Martinez

Regulatory Operations Director

Specialty Pharma

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