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Eligibility

B.Pharm Passed with min 50% for Gen & 45% for SC/ST/OBC and Govt. College/Univesity may asked GPAT additionally

Duration

2 Year

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)

Step-by-Step Admission Process

  1. Course Enquiry

    • Submit your enquiry online or directly contact our counseling team via Call or WhatsApp.

  2. Free Career Counseling

    • Get personalized guidance on course selection, eligibility, colleges, fees, and career scope.

  3. Eligibility Check & Document Verification

    • Our experts verify your academic eligibility and documents as per university norms.

  4. College & Seat Selection

    • Choose the best college/university based on merit, budget, location, and availability.

  5. Application & Admission Support

    • We assist in application filling, fee payment, and admission formalities.

  6. Admission Confirmation

    • Receive official admission confirmation from the college/university.

Talk to Our Admission Experts (Interactive):

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Why Choose ADMISSION DUNIYA?

  • Pan-India admission support

  • Expert counseling for Medical, Engineering, Management & Allied courses

  • Transparent process & trusted guidance

  • End-to-end admission assistance

Core Subjects

  • Drug Regulatory Affairs

  • Pharmaceutical Quality Assurance

  • Drug Laws & Ethics

  • Validation & Qualification

  • Stability Studies

  • Pharmaceutical Documentation


Advanced & Applied Subjects

  • GMP, GLP, GCP & GDP

  • Regulatory Submissions (CTD, eCTD)

  • International Regulatory Guidelines (USFDA, EMA, ICH, WHO)

  • Quality Risk Management

  • Pharmacovigilance

  • Audit & Compliance Management


Practical & Research Components

  • 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.

Job Roles

  • Regulatory Affairs Executive / Manager

  • Quality Assurance Officer

  • Regulatory Compliance Specialist

  • Validation Executive

  • Pharmacovigilance Officer

  • Drug Safety Associate

  • Documentation Specialist

  • Audit & Compliance Executive


Employment Sectors

  • Pharmaceutical Manufacturing Companies

  • Biotechnology & Biosimilar Firms

  • Contract Research Organizations (CROs)

  • Regulatory Consulting Firms

  • Clinical Research Organizations

  • Government Drug Control Departments


Higher Studies & Certifications

  • Ph.D. in Pharmacy / Pharmaceutical Sciences

  • Professional certifications in Regulatory Affairs, Quality Systems, and Pharmacovigilance

FAQ

It is a 2-year postgraduate pharmacy program focused on drug regulations, quality systems, compliance, and global pharmaceutical approval processes.

GPAT is preferred or required by many institutes, though some universities conduct their own entrance exams.

Key subjects include Drug Regulatory Affairs, Pharmaceutical Quality Assurance, GMP/GLP/GCP, validation, stability studies, regulatory documentation, and pharmacovigilance.

Yes, it offers strong career prospects in pharmaceutical manufacturing, regulatory compliance, quality assurance, and clinical research sectors.

Graduates can work as Regulatory Affairs Executives, QA Officers, Validation Executives, Pharmacovigilance Officers, and Compliance Specialists.

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