top of page

COURSE

Diploma in Regulatory Affairs & Medical Writing

6 Months

English

Beginner & Intermediate

Instructor Led live Trainings (ILT)

Personalized MS ID

Certificate On Completion

About the Course

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 and GxP Compliance along with 6 Month Project to ensure proficiency with global standards.


Participants will gain hands-on experience in Document Authoring, Dossier preparation and Life Cycle Management.


Additionally, the course includes training on RIM (Regulatory Information Management) Product portfolio Management with 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.

Key Tools and Skills
  • Drug Discovery and Development

  • Clinical Medical Writing

  • Medico Marketing Writing

  • Regulatory Writing

  • Scientific Writing

  • ICH Suite & GxP

  • Chemistry Manufacturing Controls (CMC)

  • Labelling & Artwork Management

  • Lifecycle Management

  • Regulatory Information Management (RIM)

  • Publishing (DLP & SLP)

  • Various Applications (IND, NDA, ANDA, BLA & CTA)

  • Document Authoring

  • Dossier preparation

  • Product portfolio Management

  • Regulatory Intelligence

  • Submission coordination

  • Health Authority Queries

Click 'Enroll' to access the course map

bottom of page