USFDA Electronic Submission Gateway

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

What you'll 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
Requirements
Pharmacy Profession
Regulatory affairs associate
Pharmaceutical industry Background
Curiosity towards learning
Science education
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

Introduction to USFDA ESG

Preparation Activities for submission

Overview of registration process

Learning of application procedure

Account creation

User access information

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

Who this course is for
Pharmacy students
Pharmacy industry professionals
Research associates
Regulatory affairs officers
Regulatory affairs managers
Regulatory affairs co-ordinators
Master of pharmacy
Freshers and experienced candidates
Pharma job seekers