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COURSE

Diploma in Regulatory Affairs & Medical Writing

6 Months

2 Assessments

72 (ILTs- 64, Guest lectures 4, One on One - 4)

English

Beginner & Intermediate

Instructor Led live Trainings (ILT)

Personalized MS ID

Certificate On Completion

About the Course

This 6-month diploma course provides in-depth training on key aspects of regulatory affairs and medical writing. It covers essential topics such as Drug Discovery and Development, Regulatory Intelligence, Clinical Trial Applications, and GxP Compliance to ensure proficiency in global regulatory standards.


Participants will gain hands-on experience in CMC (Chemistry, Manufacturing & Controls), Labelling & Artwork Management, Life Cycle Management, and Submission Publishing using the ICH Suite. Additionally, the course includes training on RIMS (Regulatory Information Management Systems), Supply & Product Management, and Scientific & Clinical Medical Writing to enhance documentation and compliance skills.


This program is ideal for professionals aspiring to excel in the pharmaceutical, biotechnology, and healthcare industries by mastering regulatory frameworks and medical documentation best practices..

Key Tools and Skills from this Course.
  • Drug Discovery and Development

  • Regulatory Intelligence

  • Clinical Trail Applications

  • Regulatory Writing

  • Clinical Regulatory Affairs

  • CMC

  • Labelling & Artwork Management

  • Scientific Writing

  • Life Cycle Management

  • Submission Publishing

  • ICH Suite

  • Clinical Medical Writing

  • RIMS

  • GxP

  • Supply Management

  • Product Management

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