Welcome to Best M.Pharm College

  • M.Pharm in Regulatory Affairs
  • Guru Nanak Institute of Pharmaceutical Science & Technology (under the aegis of JIS GROUP) is the Topmost & Best Private NIRF Ranked & Accredited Pharmacy College in India, and the first in the state of West Bengal - Kolkata & in Eastern India to introduce post-graduation (M.Pharm) in Regulatory Affairs Course under Maulana Abul Kalam Azad University of Technology (MAKAUT) formerly known as West Bengal University of Technology (WBUT).
  • Regulation approvals are the major step that drives the R &D efforts of the industry to the market where the timely marketing approvals from a particular country to dominate the current global competitiveness. Some of such major international agencies include USFDA-US, EDQM-Europe, TGA-Australia, MHRA-UK and TPD-Canada, etc. During the course of studies, students have to present specific regulatory issues for a drug or device along with justification and strategy. This will help the students to acquire up-to-date knowledge, scientific and legal writing, analytic and reasoning skills as well as effective communication.
  • After completing the M. Pharm. in Drug Regulatory Affairs, (DRA) the students will be able:

To optimize regulatory procedures,

To develop documentation

To know the Regulatory processes in drug develop formulations, novel drug delivery systems and devices.

To update knowledge with new legislation in a constantly changing environment,

To know the regulatory process in drug development, formulations, novel drug delivery systems and devices.

To understand the system for the submission of DMF, e-CTD, Dossier, etc.

To understand the marketing authorization, regulatory

  • The DRA department is more focused towards current regulatory needs for development and growth of pharmaceutical sector with continuous input on advanced research in the following areas:

Regulatory affairs for clinical trials

Regulatory requirements of pharmaceuticals

Emerging Concept in Regulatory Affairs

Good Manufacturing Practice

International Regulatory Systems

National and International Drug Approvals

Pharmaceutical Biostatistics & Computer Applications

National and International Drug Approvals & Bioethics

Quality assurance in regulatory affairs

National Regulatory Affairs

Research Methodology & Pharmacological Screening

  • Eligibility & Intake :-

Candidate should have passed B.Pharma from recognized university.

Duration - 2 years

Intake - 9