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US Regulatory Affairs

This comprehensive course provides in-depth knowledge of the regulations and agencies like FDA and processes involved in developing, approving, and marketing healthcare products, including pharmaceuticals, medical devices, and biologics. These courses aim to equip professionals with the skills to navigate the complex regulatory landscape, ensuring compliance with US and international standards.

Course Instructors: Mr. Bhaumik Dinesh Modi, ROPRA Life Sciences

FREE

To enroll in this course, please contact the Admin
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Course Overview

Schedule of Classes

Start Date & End Date

Jul 19 2025 - Oct 19 2025

Course Curriculum

1 Subject

US Regulatory Course

7 Learning Materials

Introduction

US FDA's M1 to M5 structure of dossier document

PDF

Q3A(R2) Guideline

PDF

Q2 (R2)Guideline

PDF

DMF - Guideline Content and Format

PDF

Completeness Assessments for Type-II-API-DMFs-Under-GDUFA-Guidance-for-Industry

PDF

Q6A Guideline

PDF

ANDA Submissions - Content and Format

PDF

Course Instructor

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Mr. Bhaumik Dinesh Modi

1 Courses   •   2 Students

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ROPRA Life Sciences

14 Courses   •   53 Students