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An IS0 9001:2015 Certified Institute



About the course:-

Regulatory affairs is a profession developed from the desire of governments to protect public health by controlling the safety and efficacy of products in areas including pharmaceuticals, veterinary medicines, medical devices, pesticides, agrochemicals, cosmetics and complementary medicines, and by the companies responsible for the discovery, testing, manufacture and marketing of these products wanting to ensure that they supply products that are safe and make a worthwhile contribution to public health and welfare. A new class of professionals emerged to handle these regulatory matters for companies.

Objective of the course:-


Course Syllabus

Topic : 1 Introduction to RA

Topic : 2 ICH guidelines

What are ICH guidelines and their importance.

Overview of following ICH guidelines

Topic : 3 CTD – eCTD

Introduction about CTD/eCTD, origin of CTD and brief description about each section in the modules along with Hands on experience in CTD dossier compilation.

Topic : 4 Drug Development Process and Product development.

New drug development process, QSAR, pre-clinical and clinical studies, Basics of formulation development, Importance of pre-formulation studies and demonstration of product development with live project

Topic : 5 Generic Drugs

What are generic drugs, how are they equal with innovator drugs, their development process, dissolution study comparisons and overview on concept of bioequivalence studies.

Topic : 6 Drug approval procedure in US

US(FDA) Introduction, 21CFR, INDA, NDA, ANDA drug applications, Patents and their types, GDUFA, Post approval changes (Annual reports, CB-30 and prior approval supplements) and Types of DMF’s.

Topic : 7 Drug approval procedure in Europe

Drug regulatory authorities in European Union (EU), different types of approval procedures (MRP, DCP, National and Centralized Procedures), brief study on post approval changes (variations and extensions) and approval procedures for drug substance (DMF and CEP).

Topic : 8 Discussion on deficiencies received from authorities and how to address the quires effectively.

Deficiencies received from various health agencies will be discussed along with best remedial action plan. This programme helps to boost up technical skills and knowledge enhancement.

Topic : 9 Resume preparation and interview questions.

Resume meeting the latest trends with notified key words will be prepared. Interview questions shall be discussed.

Course Features

Instructor Live Sessions

There will be allocated hours of instructor with Live classroom and Simultaneously on Online.

Real Time Studies

Live project based on any of the selected use cases on the above selected Domain.


Each class will be followed by practical assignments which can be completed before the next class.

24/7 Support

We have 24x7 support team available to help you with any technical queries you may have during the course and after completion of the course with in a year.


Towards the end of the course, you will be working on a project. Sadhana Infotech certifies you as an course Expert based on the project.

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