Post Graduate Diploma in Regulatory Affairs
Post Graduate Diploma in Regulatory Affairs
Programme Overview
This programme prepares learners for regulatory roles in pharmaceuticals, biotechnology, and healthcare by covering global regulatory frameworks, submission strategies, and compliance requirements.
Programme Curriculum
Introduction to Regulatory Affairs
- Role of RA in product lifecycle
- Global regulatory environment
Regulatory Submissions
- IND, NDA, ANDA
- CTD / eCTD structure
Global Regulatory Authorities
- US FDA
- EMA
- CDSCO
Quality & Compliance
- GMP, GCP, GLP
- Audit readiness
Post-Market Surveillance
- Labeling updates
- Regulatory intelligence
Eligibility: Graduates in any discipline
Programme Duration: 3–6 months
Programme Mode: Online