Master of Pharmacy in Drug Regulatory Affairs and Quality Assurance (M.Pharm DRA & QA) is a postgraduate pharmacy program designed to train professionals in regulatory compliance, pharmaceutical quality systems, and global drug approval processes. The course focuses on ensuring that pharmaceutical products meet national and international regulatory standards related to safety, efficacy, and quality.
Students gain in-depth knowledge of drug laws, regulatory documentation, validation, Good Manufacturing Practices (GMP), Good Clinical Practices (GCP), Good Laboratory Practices (GLP), and quality management systems. The program also provides exposure to global regulatory agencies such as USFDA, EMA, WHO, and CDSCO, preparing graduates for regulatory and quality roles in the pharmaceutical industr
2 Years
Divided into 4 semesters
Includes theory subjects, practical training, seminars, industrial exposure, and a research project
Bachelor of Pharmacy (B.Pharm) degree from a PCI-approved institution
Minimum aggregate marks usually 50–55% (relaxation as per category norms)
Valid GPAT score or qualification in university/state-level entrance examination (as applicable)
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Drug Regulatory Affairs
Pharmaceutical Quality Assurance
Drug Laws & Ethics
Validation & Qualification
Stability Studies
Pharmaceutical Documentation
GMP, GLP, GCP & GDP
Regulatory Submissions (CTD, eCTD)
International Regulatory Guidelines (USFDA, EMA, ICH, WHO)
Quality Risk Management
Pharmacovigilance
Audit & Compliance Management
Regulatory Documentation & Dossier Preparation
Validation & Quality Control Practical
Industrial Training
Seminar & Case Studies
Research Project / Dissertation
(Exact syllabus may vary by university and PCI regulations.)
After completing M.Pharm in Drug Regulatory Affairs & Quality Assurance, graduates can pursue high-demand roles in pharmaceutical, biotechnology, and healthcare industries.
Regulatory Affairs Executive / Manager
Quality Assurance Officer
Regulatory Compliance Specialist
Validation Executive
Pharmacovigilance Officer
Drug Safety Associate
Documentation Specialist
Audit & Compliance Executive
Pharmaceutical Manufacturing Companies
Biotechnology & Biosimilar Firms
Contract Research Organizations (CROs)
Regulatory Consulting Firms
Clinical Research Organizations
Government Drug Control Departments
Ph.D. in Pharmacy / Pharmaceutical Sciences
Professional certifications in Regulatory Affairs, Quality Systems, and Pharmacovigilance
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