Interact Innovate Industry ready
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
