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Bhagwan Mahavir College of Pharmacy

Regulatory Affairs


Regulatory Affairs Program


Regulatory affairs is an industry that oversees how drugs, foods and medical products are developed, tested, manufactured, marketed, and distributed to certify that they meet regulatory standards for human use. Regulatory affairs professionals are responsible for ensuring manufacturers’ compliance with applicable global legislative and regulatory requirements at each stage of product development. In the drug, medical device and biologic product industries, these phases include: research and development, clinical trials, regulatory submissions, manufacturing, marketing, distribution, reimbursement, and post-market surveillance. This course is designed to impart fundamental knowledge on various Good Regulatory Practices viz., cGMP, GLP, GALP and GDP for Pharmaceuticals, Cosmetics, Food & Nutraceuticals, Medical devices, In-vitro Diagnostic Medical Devices (IVDs) and biological products and understand the rationale behind these requirements and will propose ways and means of complying with them. It prepares the students to learn in detail on the regulatory requirements, documentation requirements, and registration procedures for marketing the drug products and cosmetics in regulated and semi-regulated countries. The various job opportunities are as Regulatory Compliance & Regulatory affair assistant, Regulatory affair associates, Preparation of Registration Dossier, Documentation, Administrator and Medical Information Associates, Regulatory Affair Consultants, Regulatory Food Safety Scientist etc.

1040303101 – Good Regulatory Practices Theory
1040303102 – Documentation and Regulatory Writing Theory
1040303103 – Clinical Research Regulations Theory
1040303104 – Regulations and Legislation Theory
1040303105 – Regulatory Affairs Practical I
1040303106 – Seminar-Assignment

1040303201 – Regulatory Aspects of Drugs and Cosmetics
1040303202 – Regulatory Aspects of Herbal and Biologicals
1040303203 – Regulatory Aspects of Medical Devices
1040303204 – Regulatory Aspects of Food and Nutraceuticals
1040303205 – Regulatory Affairs Practical II
1040303206 – Seminar-Assignment

1040301301 – Research Methodology and Biostatistics
— – Journal Club
— – Discussion and Presentation – Proposal Presentation
— – Research Work

— – Journal Club
— – Research Work
— – Discussion and Final Presentation