Regulatory Affairs US-FDA Electronic Submission Gateway tool
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
- Procedure for submission of electronic data to FDA
- Pharmacy Profession
- Regulatory affairs associate
- Pharmaceutical industry Background
- Curiosity towards learning
- Science education
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
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
- Ph. D students and professional
- Regulatory affairs freshers
I Am Mahesh Pratapwar.
I am Pharma Professional, having skill of Pharmaceutical Product development and Complying with Regulatory Specifications for Pharmaceutical products according to guidelines of US/Europe/CDSCO.
I have completed M.Pharm (P.Ceutics).
Work experience more than 6 years in Pharma Industry.
Regulatory Affairs plays a crucial role in the pharmaceutical industry and is involved in all stages of drug development and also after drug approval and marketing. ... Pharmaceutical companies use all the data accumulated during discovery and development stages in order to register the drug and thus market the drug.
Skills: Formulation & Development, Stability studies, QbD, OSD, Oral Liquids, Topical/Derma, DRA, CTD & eCTD, Plant exposure, Bioequivalence, DoE, etc...
Published more than 3 Research and review articles in high impact journals.
Top 9 pharma courses has been published on Udemy
1. Pharma Drug Regulatory Affairs Course - DRA 2022
2. Pharmaceutical Clinical Bioequivalence study (BA/BE) course
3. Clinical Research Certificate Course
4. Pharma eCTD & CTD preparartion + Sumbmission course
5. Complete Qbd: Quality by Design in Pharmaceutical Product Development
6. DOE-Design of Experiment in pharmaceutical development
7. Regulatory Affairs USFDA Electronic Submission Course
8. GMP Tablet Manufacturing Technology & Pharmaceutical Practices.
9. IPQC tests for Pharmaceutical Tablet dosage form
Other published courses:
Complete Website Design/Development Course (without code or programing language)