About M.Pharm Regulatory Affairs

The regulatory framework and the scope of law has been on a continuous expansion in regards to the manufacturing and destribution of pharmaceutical products, and such has created a demand for individuals with an indepth expertise in the regulations relating to the field. To meet this demand, the Faculty of Pharmacy offers a two year postgraduate program in Regulatory Affairs  which seeks to provide the students with an indepth understanding of the legal aspects to do with the industry.  As of today, all pharmaceutical and biological products are governed by strict regulations set by the relevant regulatory authorities in the respective countries and regions of the world. Therefore the Regulatory Affairs program has been developed inorder to equip specific experts within the Pharmacy industry with the ability to provide protection to the  public health, by controlling the safety and efficacy of products in areaso of pharmaceuticals. The Faculty of Pharmacy has been equipped with the most State of the Art Facilties for research and experimentation which seeks to provide the students with an indepth understanding into the various aspects of the field. The students also go on to pursue this program under the instruction of expert faculties and lecturers who go on to shape the pathways of the students in preparation of their careers. Therefore pursuing this program will provide the students with an indepth understanding of the regulatory frameworks of Pharmacy.


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M.Pharm Regulatory AffairsProgram Outcomes

Why Study M.Pharm Regulatory Affairs

There has been an ever-growing demand for experts who are trained in this field and students who get to receive this know-how will get various career avenues in advising on the legal and scientific restraints and requirements, and collect, collate, and evaluate the scientific data that their research and development colleagues are generating. The regulatory affairs program has been custom designed to meet the needs and requirements of the contemporary industry.


An ability to apply innovative medicinal and treatment modalities for diseases and viruses which may affect the well-being and livelihood of humanity as a whole.

Drug Inspector

The ability to develop the relevant soft skills and professional ethics which are vital for navigating the career landscape.

Drug Inspector
Regulations Affairs Officer

Regulations Affairs Officer

An ability to work in providing assistance towards ensuring and providing the necessary guidance in regulations and ensuring checks within the system.

Pharmaceutical Sales

An ability to make contributions to the economic scope of pharmacy through driving sales and effective marketing strategies

Pharmaceutical Sales

Duration: 2 years (Semester System)



Constituent College of Parul University


Eligibility Criteria

The candidate shall have passed B.Pharm with minimum 55% For General Category (50% for SC/ST/SEBC candidates) at qualifying exam for M.Pharm Courses


Mode of Admission

For admissions please visit our portal to register/login yourself and proceed ahead with your admission application.

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M.Pharm Regulatory Affairs feesFees


M.Pharm Regulatory Affairs

₹ 1,21,800/- Annually*

* Tuition Fees may vary depending on the Country/ State in which the candidate has passed their qualifying examination.

M.Pharm Regulatory Affairs CurriculumCurriculum

Good Regulatory Practices

Documentation and Regulatory Writing

Clinical Research Regulations

Regulations and Legislation for Drugs & Cosmetics, Medical Devices, Biologicals & Herbals, and Food & Nutraceuticals In India and Intellectual Property Rights

Regulatory Affairs Practical I


Regulatory Aspects of Drugs &Cosmetics

Regulatory Aspects of Food & Nutraceuticals

Regulatory Aspects of Herbal & Biologicals

Regulatory Affairs Practica lII

Regulatory Aspects of Medical Devices



Research Methodology and Biostatistics

Discussion/Presentation (Proposal Presentation)

Journal Club

Research Work


M.Pharm Regulatory Affairs Curriculum Laboratories


Research and Development Lab

As a way of promoting research, innovation and novel ideas in the field of pharmacy, Parul University, has a designated research and development laboratory.


Computer Labs

Pharmacy education is becoming highly digital thus it maintains close ties with the contemporary trends in innovative technology therefore specific computer labs are designated for the pharmacy

https://paruluniversity.ac.in/Research lab

Research lab

https://paruluniversity.ac.in/Practical lab

Practical lab

https://paruluniversity.ac.in/Quality assurance lab

Quality assurance lab



M.Pharm Regulatory Affairs CurriculumActivities

GUJCOST National Seminar on “Quality Management System and Statistical Control – Key tools for Regulatory Compliance”

The Faculty of Pharmacy organized a GUJCOST sponsored one day National Seminar on the theme 'Quality Management System and Statistical Control, Key tools for Regulatory Compliance' on 29th December, 2018. Luminaries and Academicians from the Pharmaceutical Fraternity participated in this National Seminar which also received huge support from renowned Pharmaceutical Industries such as Mil Laboratory, Vasu Health Care Limited, Sharma Pharmaceutical Industry, Symbiotic Inc, West Coast Pharma etc

Workshop on Frontier Techniques in Preclinical Research

The workshop on 'Frontier Techniques in Preclinical Research' was organized by the Faculty of Pharmacy, with an aim to provide a platform to academicians and budding pharmacists to expand their knowledge and skills in the field of preclinical research with 61 participants, from different colleges and institutes of Gujarat. Mr. Vineet Gopal, Executive Director, Gentech Marketing and Distribution Pvt. Ltd., Delhi, graced the inaugural function as chief guest. First scientific session was conducted by Dr. Kirti Patel, Associate Professor, Department of Pharmacy, M S University, Baroda. She narrated about the newer avenues of cancer research.

Industrial Visit At Alkem Laboratories

As a way of enhancing the career competencies of the students, the Faculty of Pharmacy organized an industrial visit for VIIth Sem B. Pharm students to Alkem Laboratories Private Limited at Nani Daman. The students were divided in three groups consisting of 20 students in each group. The students and faculties were taken around the departments of Alkem Laboratories by their staff and explained in detail of the various equipments and processes.

Pharma Fest

Pharma Fest is an annual festival held on World pharmacy day which celebrates and honours the significant role which the field of Pharmacy has made towards the development and welfare of humanity as a whole. The platform features avenues for student creative expression through various curricular and co-curricular activities. For the Pharmacy students the platform develops and shapes their interpersonal skills and personal confidence to match the needs of the industry and enhance their employability.