M.Pharm Pharmaceutical Regulatory Affairs at MCOPS

Manipal

Your gateway to global pharmaceutical compliance and regulatory excellence

The Master’s in Pharmaceutical Regulatory Affairs at MCOPS is the earliest postgraduate program in pharmaceutical marketing, now expanded to include regulatory sciences and management. You gain skills to manage regulatory submissions, audits, and quality compliance, with exposure to global regulations for drugs, biologics, medical devices, herbals, nutraceuticals, and cosmetics.

The program integrates advanced laboratories, regulatory software tools, and industry-linked projects. Internships, collaborative research, and global exchange opportunities provide hands-on experience for careers in regulatory affairs, quality assurance, and consultancy.

Program Highlights

Specialised Regulatory Focus: Concentrates on Good Regulatory Practices and compliance frameworks for the global pharma industries.

Dossier Preparation Training: Learn industry-standard eCTD submission formats for drugs, biologics, and devices.

Practical Industry Exposure: Engage in audits, inspections, and compliance systems through laboratory and field experience.

Global Collaborations: Benefit from partnerships with top pharmaceutical companies and international universities.

Advanced Infrastructure: Access regulatory compliance labs, drug safety centres, and software tools for hands-on learning.

Career-Ready Skillset: Gain expertise in regulatory writing, documentation, clinical research, and consultancy.

Lab Work

Advanced laboratories with regulatory compliance tools, central cell and molecular labs, animal cell culture, drug testing facilities, and ADR monitoring centres.

Industry Projects

Industry-linked dissertations and projects with leading pharma and biotech companies to gain real-world regulatory experience.

Internships

Undertaking mandatory internships in regulatory affairs, quality assurance, and clinical research, often integrated with PG dissertation projects.

Lab Work

Advanced laboratories with regulatory compliance tools, central cell and molecular labs, animal cell culture, drug testing facilities, and ADR monitoring centres.

Lab Work

Advanced laboratories with regulatory compliance tools, central cell and molecular labs, animal cell culture, drug testing facilities, and ADR monitoring centres.

Program Eligibility

Qualification

You must successfully complete B.Pharm from a Pharmacy Council of India (PCI) or equivalent from a recognized university with a minimum of 55% aggregate marks.

You must also have registration with the State Pharmacy Council, or obtain it within one month of admission.

And

Submit a migration certificate from the university where you completed your B.Pharm degree.

Scholarships

Manipal Academy of Higher Education (MAHE) Manipal awards scholarship for its Under Graduate (UG) and Post Graduate (PG) students under the following categories

Degree / Marks/ Board

UG: 80% aggregate in 12th (as per admission criteria) PG: 70% aggregate in Undergraduate (UG)

Entrance Test

As applicable to the respective program

Scholarship on program fee

10% fee waiver

Scholarship on hostel fee

Not Applicable

Room type

Not Applicable

Monthly Stipend

Not Applicable

Continuation of Scholarship

The award of Fee Waiver for the subsequent years will be the same as given at the time of admission in the first year. Scholarship will be extended in the subsequent year only to those students who have cleared all subjects in the University Examinations of previous year before the due date for payment of annual program fee. Students who are promoted to next year with failures (F) / Incomplete (I) / Detention (DT) grades, will NOT be eligible for fee waiver for that academic year. Fee Waiver will be forfeited in the instances of irregularity in attendance, proven charges of indiscipline, bringing disrepute to the Department / Institution / University etc.

Withdrawal Policy

In case the candidate leaves the course before the course completion (for any reason), he / she MUST reimburse the total program fee (as per Prospectus 2025) for the years of scholarship utilized, back to MAHE Manipal.

To Know More

Program Highlights

Specialised Regulatory Focus: Concentrates on Good Regulatory Practices and compliance frameworks for the global pharma industries.

Dossier Preparation Training: Learn industry-standard eCTD submission formats for drugs, biologics, and devices.

Practical Industry Exposure: Engage in audits, inspections, and compliance systems through laboratory and field experience.

Global Collaborations: Benefit from partnerships with top pharmaceutical companies and international universities.

Advanced Infrastructure: Access regulatory compliance labs, drug safety centres, and software tools for hands-on learning.

Career-Ready Skillset: Gain expertise in regulatory writing, documentation, clinical research, and consultancy.

Lab Work

Advanced laboratories with regulatory compliance tools, central cell and molecular labs, animal cell culture, drug testing facilities, and ADR monitoring centres.

Industry Projects

Industry-linked dissertations and projects with leading pharma and biotech companies to gain real-world regulatory experience.

Internships

Undertaking mandatory internships in regulatory affairs, quality assurance, and clinical research, often integrated with PG dissertation projects.

Lab Work

Advanced laboratories with regulatory compliance tools, central cell and molecular labs, animal cell culture, drug testing facilities, and ADR monitoring centres.

Lab Work

Advanced laboratories with regulatory compliance tools, central cell and molecular labs, animal cell culture, drug testing facilities, and ADR monitoring centres.

Program Details

Outcomes
Careers

Upon completion of this program, you can:

Master regulatory documentation to prepare and submit compliance dossiers for drugs, devices, and biologics.

Develop audit competence to conduct regulatory audits and inspections, adhering to international standards.

Enhance knowledge and gain expertise in global regulatory frameworks, including USFDA, EMA, and CDSCO.

Inculcate consultancy skills and advise pharmaceutical organisations on compliance and regulatory processes.

Become industry-ready and apply practical skills in clinical research, quality management, and dossier preparation.

Secure global opportunities and prepare for international roles in regulatory affairs or pharmaceutical R&D.

Program Eligibility

Qualification

You must successfully complete B.Pharm from a Pharmacy Council of India (PCI) or equivalent from a recognized university with a minimum of 55% aggregate marks.

You must also have registration with the State Pharmacy Council, or obtain it within one month of admission.

And

Submit a migration certificate from the university where you completed your B.Pharm degree.

Curriculum and Fees

Year 1
Year 2

Foundation in pharmaceutical regulatory frameworks, intellectual property rights, pharmaceutical marketing, consumer behaviour, and health economics. You also train in research methodology and biostatistics to strengthen your analytical and academic skills.

Program Duration

2 Years

Total Program Fee

General:

INR 10,24,000

Total Program Fee

NRI/Foreign:

USD 16,100

Scholarships

Manipal Academy of Higher Education (MAHE) Manipal awards scholarship for its Under Graduate (UG) and Post Graduate (PG) students under the following categories

Degree / Marks/ Board

UG: 80% aggregate in 12th (as per admission criteria) PG: 70% aggregate in Undergraduate (UG)

Entrance Test

As applicable to the respective program

Scholarship on program fee

10% fee waiver

Scholarship on hostel fee

Not Applicable

Room type

Not Applicable

Monthly Stipend

Not Applicable

Continuation of Scholarship

Withdrawal Policy

To Know More

M.Pharm Pharmaceutical Regulatory Affairs at MCOPS

Your gateway to global pharmaceutical compliance and regulatory excellence

Program Highlights

Upon completion of this program, you can:

Industry and Academia Connect

Qualification

2 Years

INR 10,24,000

USD 16,100

Program Highlights

Upon completion of this program, you can:

Industry and Academia Connect

Qualification

2 Years

INR 10,24,000

USD 16,100