International Journal Of Drug Regulatory Affairs

Table of Contents

• REVIEW ARTICLE

  A Comparative Review of Fast-Track Generic Drug approvals: Criteria and Timelines across FDA, Swissmedic, MHRA, and PMDA

  • Author: Sakshi Nagesh Deshmukh, Syed Shoaib Ali, Suchita Anand Shirole
  • DOI: 10.22270/ijdra.v13i4.794

• Comparison and Registration Pathway of Nutraceuticals in Canada, India, Australia, Japan and South Korea

  • Author: Nusrathunisha Sathik Fathimabeevi, Charumathi Panneerselvam, Saba Maanvizhi
  • DOI: 10.22270/ijdra.v13i4.813

• Data Integrity in Pharmaceuticals

  • Author: S Madhanraj, A Anton Smith
  • DOI: 10.22270/ijdra.v13i4.816

• Post-Market Surveillance Evolution: Pharmacovigilance 2.0 and the future of global Drug Safety

  • Author: Shanmugapriya Prabhu, Saba Maanvizhi
  • DOI: 10.22270/ijdra.v13i4.817

• A Strategic Analysis of Work-Sharing: Access Consortium, Project Orbis, and Project Optimus

  • Author: Jonali Ramani
  • DOI: 10.22270/ijdra.v13i4.818

• CASE STUDY

  From Reviewer to Consultant: Transforming Regulatory Affairs in the MDR Transition

  • Author: Holger Wagner
  • DOI: 10.22270/ijdra.v13i4.819

• REVIEW ARTICLE

  Artificial Intelligence in Pharmaceutical Regulatory Affairs and Medical Science Liaison Activities: A Comprehensive Review

  • Author: Sayashree Ananthan
  • DOI: 10.22270/ijdra.v13i4.820

• RESEARCH ARTICLE

  The protective effects of almond milk against hydrogen peroxide damage in Arpe-19 cell line and its biological effects

  • Author: Gulcin Alp Avci
  • DOI: 10.22270/ijdra.v13i4.825

• REVIEW ARTICLE

  Clinical Research Regulation in India and Brazil: An Overview of Current Frameworks and Implementation Gaps

  • Author: Rohan Kailash Shinde, Lokesh P. Kothari
  • DOI: 10.22270/ijdra.v13i4.826

• Evolution of Clinical Trial Regulations in Cote D’Ivoire

  • Author: Paule Mireille Alloukou-Boka, Anne-Cinthia Amonkou-N’Guessan, Akadjé Richard Alloukou, Marie France Nanguy, Aziz Flores Kamelan, Franck Habib Gauze, Antoine Serge Amari
  • DOI: 10.22270/ijdra.v13i4.829

• Management of Packaging Artwork Design for Medicines in the Pharmaceutical Industry: Standardised Labeling and Package Leaflet Requirements and their Assessment Process in the European Centralised Procedure

  • Author: Rabab Abdo Mohamed Fadlelmula
  • DOI: 10.22270/ijdra.v13i4.831