Regulatory Affairs US-FDA Electronic Submission Gateway tool



USFDA, ESG, eCTD, PSUR, Electronic communication, Data submission tool, Regulatory affairs,

What you will learn

USFDA-Electronic submission gateway

Submission of electronic information to USFDA

Submission of eCTD through online submission tool

Preparation activities for submission

Application for account generation

Regulatory affairs

Guidance for Approval of Pharmaceutical Product

Generic pharmaceutical product registration

Electronic communication between USFDA and Applicant

Description

If you Regulatory affairs profession and you are not aware about ESG (Electronic Submission gateway, then this course will make you specialist in handling regulatory hurdles. You can easily get Approval for your registered product in less time.

The Food and Drug Administration (FDA) Electronic Submissions Gateway (ESG) is an Agency-wide solution for accepting electronic regulatory submissions.

The FDA ESG is a highly scalable, easily available, high performance and secure exchange point for FDA and its partners to transact a variety of documents and submissions over industry-standard protocols.

The FDA ESG enables the secure submission of premarket and postmarket regulatory information for review. The FDA ESG enables the FDA to process regulatory information automatically, functioning as a single point of entry for receiving and processing all electronic submissions in a highly secure environment.

The FDA ESG complies with secure Hypertext Transfer Protocol (HTTP) messaging standards and uses digital certificates for secure communication. The electronic submission process encompasses the receipt, acknowledgment of receipt (to the sender), routing and notification (to a receiving Center or Office) of the delivery of an electronic submission.


FDA ESG provides two methods, WebTrader (WT) and AS2, for making submissions to FDA. FDA ESG has been in production since 2006 and is used by 100s of users to send 1,000s of submissions every day.

eMDR uses the FDA Electronic Submissions Gateway (ESG), an agency-wide entry point for all electronic submissions, to receive electronic MDRs. The FDA ESG (also referred to as the ESG or the Gateway):


  • Enables the FDA to process regulatory submissions automatically
  • Functions as a single point of entry for the receipt and processing of all electronic submissions in a secure
    environment that complies with secure messaging standards
  • Serves as a conduit, or “highway,” along which submissions travel to reach their final FDA destination
  • Automatically routes submissions to the appropriate FDA Center or Office.

USE THE FDA ESG TO SAVE TIME & IMPROVE OUTCOME OF YOUR DEVICE SUBMISSION

One of the biggest advantages of using the FDA ESG solution is how much time it can save you once you’re ready for your device submission. You can confirm that your submission was received by FDA almost immediately and say goodbye to long wait times that come standard with snail mail.

Of course, you still need to put the time into making a strong case for your device submission; and for that, you need a robust document management system that serves as a single source of truth for all information you’ll need. This is often an area where medical device companies trip up in their submissions.

Your submission could easily consist of years worth of documents, records, and activities. All of that information must be properly managed and kept in a secure, up-to-date system. The last thing you would want is for all of your hard work and progress to be in vain after using an efficient document management tool that let things fall through the cracks.

One of the surest ways to improve the outcome of your device submission is by using a reliable eQMS to manage all of your documentation. Greenlight Guru is purpose-built for medical device companies and comes fully validated out-of-the-box with dedicated workflows, specifically, Document Management Software along with other workflows for every stage of the product lifecycle.

Benefits of course:

  1. Introduction to USFDA ESG
  2. Preparation Activities for submission
  3. Overview of registration process
  4. Learning of application procedure
  5. Account creation
  6. User access information
  7. Learn Regulatory submission tool

Eligibility for course:

  • Any Pharma industry profession
  • Regulatory affairs Associate
  • M. Pharmacy graduates/undergraduates
  • B. Pharmacy graduates/undergraduates
  • Regulatory affairs job seekers
English
language

Content

Introduction

Introduction
Overview of Registration Process

Preparatory Activities

Letter of Non Repudiation Agreement
Obtaining Digital Certificate
Understand Submission Guidelines
Naming Conventions
Determine Submission Methods
Connection Requirements

FDA ESG WEB INTERFACE ELECTRONIC SUBMISSIONS

FDA ESG WEB INTERFACE ELECTRONIC SUBMISSIONS

Congratulations and Thank you

Congratulations and Thank you

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