Department of Pharmaceutical Regulatory Sciences

The Master of Pharmacy (M.S Pharm) programme in “Pharmaceutical Regulatory Sciences” is committed to provide quality education and practical training in pharmaceutical regulatory sciences through adherence to national and international regulatory standards and to develop competent professionals with strong ethical values, scientific knowledge, and regulatory expertise to the evolving needs of the pharmaceutical and healthcare industries.

The Master of science in “Pharmaceutical Regulatory Sciences” program at National Institute of Pharmaceutical Education and Research Hajipur is designed as “Industry oriented program” and established from the academic session 2026-27 with the vision of developing skilled professionals in pharmaceutical regulatory sciences and healthcare compliance. The syllabus of the program has been designed by core industry experts. The department aims to provide specialized education and practical training in national and international regulatory frameworks governing pharmaceuticals, biologics, medical devices, cosmetics and related healthcare products.

The department shall focus on areas such as regulatory documentation, dossier preparation, quality assurance, clinical trial regulations, pharmacovigilance, intellectual property rights, GMP compliance, and electronic submissions in CTD/eCTD formats. The curriculum is designed in alignment with the requirements of regulatory agencies such as CDSCO, USFDA, EMA, WHO, and ICH guidelines to prepare students for global pharmaceutical and healthcare industries.

The department also aims to promote industry-oriented learning through practical training, case studies, workshops, industrial interactions, and research activities. Students will gain exposure to modern regulatory practices, scientific writing, product registration procedures, and compliance management systems essential for pharmaceutical product development and lifecycle management.

With the increasing global demand for regulatory professionals, Pharmaceutical Regulatory Sciences programme is envisioned to emerge as a centre of excellence in regulatory education, research, and professional training, contributing significantly to the growth of the pharmaceutical sector and healthcare regulation in India and abroad.

The graduates of this programme would be suitable to work and conduct research on dynamic regulatory global environment of pharma, biopharma, medical device and cosmeceutical industries.