Review

• Comparative Study of Regulatory Requirement and Approval Process for Drugs in India, US and Europe

  Suchita Anand Shirole, Syed Shoaib Ali

  Pages 1-17

  • View pdf Abstract Download pdf DOI 10.22270/ijdra.v14i3.805
• Electronic Product Information Leaflet (ePIL): Opportunities, Challenges, and Future Directions

  Chaitanya Vitthal Shinde, Trupti Mallikarjun Rajmanya, Kranti Limbajirao Satpute, Pratima Dattrao Shinde, Vishwajit Shivaji Buwa, Avinash Kamlakar Pandit, Vijay Sheshrao Utekar

  Pages 18-26

  • View pdf Abstract Download pdf DOI 10.22270/ijdra.v14i3.839
• Regulatory Approval of Ferric Carboxy Maltose Injection 50mg/ml: A Comparison Across South Africa, Singapore and Saudi Arabia

  Nikunj Sureliya, Zuki Patel, Vinit Movaliya, Niranjan Kanaki, Nirav Patel, Maitreyi Zaveri

  Pages 27-32

  • View pdf Abstract Download pdf DOI 10.22270/ijdra.v14i3.882
• Comparative Evaluation of Regulatory Registration & Approval Pathways for Semaglutide 14 mg Tablet in Emerging South American Markets: Chile, Peru and Bolivia

  Vishesh Modi, Zuki Patel, Vinit Movaliya, Niranjan Kanaki, Maitreyi Zaveri

  Pages 33-39

  • View pdf Abstract Download pdf DOI 10.22270/ijdra.v14i3.884
• Regulatory Frameworks for Strengthening Pharmaceutical Supply Chain Security: A Comparative Analysis of EU-FMD and US-DSCSA

  Isha Makadia, Zuki Patel, Vinit Movaliya, Maitreyi Zaveri, Rahul Nayak, Niranjan Kanaki

  Pages 40-45

  • View pdf Abstract Download pdf DOI 10.22270/ijdra.v14i3.887
• Navigating Regulatory Diversity: A Comparative Study of Drug Product Registration Frameworks in Malaysia, Ghana, Kuwait and India

  Khushi Hiteshkumar Gor, Zuki Patel, Vinit Movaliya, Maitreyi Zaveri, Shirish Patel, Niranjan Kanaki

  Pages 46-55

  • View pdf Abstract Download pdf DOI 10.22270/ijdra.v14i3.888
• Regulatory Trends and Challenges in Pharmaceutical Submissions: A Critical Analysis of Health Authority Requirements on Nitrosamine Impurities, Elemental Impurities, Forced Degradation and Genotoxicity

  Darshan Mistry, Zuki Patel, Vinit Movaliya, Niranjan Kanaki, Shruti Kharidia, Maitreyi Zaveri

  Pages 56-60

  • View pdf Abstract Download pdf DOI 10.22270/ijdra.v14i3.890
• Decoding FDA Complete Response Letters: Regulatory Challenges and Strategies for Successful Drug Approval

  Mukti Kapdi, Maitreyi Zaveri, Zuki Patel, Niranjan Kanaki, Pragnesh Donga, Vinit Movaliya

  Pages 61-67

  • View pdf Abstract Download pdf DOI 10.22270/ijdra.v14i3.892
• A Comparative Analysis of Drug Marketing Authorization Procedures in Canada and the European Union

  Vinuthna Rallapalli, Sundar Sankaralingam, Vengalasetti Nikita Devi

  Pages 68-76

  • View pdf Abstract Download pdf DOI 10.22270/ijdra.v14i3.900
• Comparative Evaluation of Nitrosamine Impurity Control Strategies in USFDA, EMA, and WHO Pharmaceutical Submissions

  Subalakshmi K, Immaculate Sherlin Sheridon Vaz, Ramesh S

  Pages 77-91

  • View pdf Abstract Download pdf DOI 10.22270/ijdra.v14i3.905
• Navigating Global Regulatory Frameworks: A Review of Submission Frameworks, Approvals and Timelines Across the FDA, EMA and MHRA

  Vijayalakshmi Deivasikamani, Tanushree Saxena

  Pages 92-105

  • View pdf Abstract Download pdf DOI 10.22270/ijdra.v14i3.918