International Journal Of Drug Regulatory Affairs

Table of Contents

• REVIEW ARTICLE

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

  • Author: Suchita Anand Shirole, Syed Shoaib Ali
  • DOI: 10.22270/ijdra.v14i3.805

• Electronic Product Information Leaflet (ePIL): Opportunities, Challenges, and Future Directions

  • Author: Chaitanya Vitthal Shinde, Trupti Mallikarjun Rajmanya, Kranti Limbajirao Satpute, Pratima Dattrao Shinde, Vishwajit Shivaji Buwa, Avinash Kamlakar Pandit, Vijay Sheshrao Utekar
  • DOI: 10.22270/ijdra.v14i3.839

• Regulatory Approval of Ferric Carboxy Maltose Injection 50mg/ml: A Comparison Across South Africa, Singapore and Saudi Arabia

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

  • Author: Vishesh Modi, Zuki Patel, Vinit Movaliya, Niranjan Kanaki, Nirav Patel, Maitreyi Zaveri
  • DOI: 10.22270/ijdra.v14i3.884

• Regulatory Frameworks for Strengthening Pharmaceutical Supply Chain Security: A Comparative Analysis of EU-FMD and US-DSCSA

  • Author: Isha Makadia, Zuki Patel, Vinit Movaliya, Maitreyi Zaveri, Rahul Nayak, Niranjan Kanaki
  • DOI: 10.22270/ijdra.v14i3.887

• Navigating Regulatory Diversity: A Comparative Study of Drug Product Registration Frameworks in Malaysia, Ghana, Kuwait and India

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

  • Author: Darshan Mistry, Zuki Patel, Vinit Movaliya, Niranjan Kanaki, Shruti Kharidia, Maitreyi Zaveri
  • DOI: 10.22270/ijdra.v14i3.890

• Decoding FDA Complete Response Letters: Regulatory Challenges and Strategies for Successful Drug Approval

  • Author: Mukti Kapdi, Maitreyi Zaveri, Zuki Patel, Niranjan Kanaki, Pragnesh Donga, Vinit Movaliya
  • DOI: 10.22270/ijdra.v14i3.892

• A Comparative Analysis of Drug Marketing Authorization Procedures in Canada and the European Union

  • Author: Vinuthna Rallapalli, Sundar Sankaralingam, Vengalasetti Nikita Devi
  • DOI: 10.22270/ijdra.v14i3.900

• Comparative Evaluation of Nitrosamine Impurity Control Strategies in USFDA, EMA, and WHO Pharmaceutical Submissions

  • Author: K Subalakshmi, Immaculate Sherlin Sheridon Vaz, S Ramesh
  • DOI: 10.22270/ijdra.v14i3.905

• Navigating Global Regulatory Frameworks: A Review of Submission Frameworks, Approvals and Timelines Across the FDA, EMA and MHRA

  • Author: Vijayalakshmi Deivasikamani, Tanushree Saxena
  • DOI: 10.22270/ijdra.v14i3.918