International Journal Of Drug Regulatory Affairs

Table of Contents

• REVIEW ARTICLE

  Application of Failure Modes and Effects Analysis (FMEA) for Conducting Multiple Risk Assessments in a New Pharmaceutical Facility

  • Author: Harsh Patel, Vinit Movaliya, Niranjan Kanaki, Maitrey Zaveri, Rajnish Verma, Zuki Patel
  • DOI: 10.22270/ijdra.v14i2.868

• Comparative Analysis of Regulatory Approval Processes for Medical Devices in India and the European Union

  • Author: Sarveshwar Jeevan Lokhande, Vaibhav Janak Yede, Nirbhay Baburao Chalmale, Rohit Ramnivas Sarda, Kranti Limbajirao Satpute, Sagar Suresh Gilda
  • DOI: 10.22270/ijdra.v14i2.873

• Automated Classification of Post-Approval Changes Using Regulatory Intelligence Models

  • Author: Kiran Kumar Gande
  • DOI: 10.22270/ijdra.v14i2.874

• Regulatory Frameworks Governing Pharmaceutical Manufacturing Site Transfers: A Comparative Review of WHO, EMA, and US FDA Approaches

  • Author: Immaculate Sherlin Sheridon Vaz, K Subalakshmi, S Ramesh
  • DOI: 10.22270/ijdra.v14i2.875

• Drug Safety of Antihypertensive Medicines Using Pharmacovigilance Data: Signal Management Through Traditional Methods Versus Process Automation

  • Author: Yash Patel, Vinit Movaliya, Niranjan Kanaki, Zuki Patel, Mrugank Parmar, Maitreyi Zaveri
  • DOI: 10.22270/ijdra.v14i2.880

• A Comparative Study of Medical Device Regulatory Frameworks: India vs. the European Union

  • Author: Amisha Patel, Niranjan Kanaki, Zuki Patel, Maitreyi Zaveri, Vinit Movaliya
  • DOI: 10.22270/ijdra.v14i2.881

• A Comparative Study of the Regulatory Landscape for Pre-filled Syringes (PFS) in the Philippines and Uganda

  • Author: Bhumi Solanki, Maitreyi Zaveri, Zuki Patel, Vinit Movaliya, Rahul Nayak, Niranjan Kanaki
  • DOI: 10.22270/ijdra.v14i2.883

• Regulatory Lifecycle Management of Solid Oral Dosage Forms in Nigeria and Kenya

  • Author: Shreya Kumar, Zuki Patel, Niranjan Kanaki, Maitreyi Zaveri, Shruti Kharidia, Vinit Movaliya
  • DOI: 10.22270/ijdra.v14i2.885

• Comparative Study of CTD Modules 3, 4, and 5: Generic Drugs versus Complex Generics (Liposomal Injectables) in the United States, European Union, and Japan

  • Author: Manasvi Kotadia, Vinit Movaliya, Niranjan Kanaki, Maitreyi Zaveri, Shailesh Khacharia, Zuki Patel
  • DOI: 10.22270/ijdra.v14i2.889

• Lifecycle Continuity Through Regulatory Compliance: A Comparative Evaluation of Post-Approval Change Strategies for APIs and Drug Products Under the Regulatory Frameworks of Saudi Arabia, the United States, Australia, and Eurasia

  • Author: Sharlee Krunalkumar Shah, Vinit Movaliya, Zuki Patel, Maitreyi Zaveri, Akshita Parekh, Niranjan Kanaki
  • DOI: 10.22270/ijdra.v14i2.891

• An Analytical Study of Selected Bulk Drug Manufacturers in Andhra Pradesh and Telangana: SEZ Status, Regulatory Framework, Compliance, Oversight, and Workforce Welfare and Safety

  • Author: Vijaya Ratna Jayanti, Sarveswara Rao Mandavilli, Heera Battu
  • DOI: 10.22270/ijdra.v14i2.906

• Overview of Structural Specifications and Validation of eCTD (v3.2.2): An Elucidation of the General Architecture of EU Module 1 and GCC Module 1

  • Author: Rabab Abdo Mohamed Fadlelmula
  • DOI: 10.22270/ijdra.v14i2.914

• Driving First‑Cycle ANDA Approvals Through Strategic Regulatory Planning

  • Author: Piyush Modi, Jigneshkumar Modasiya, Dhaval Desai
  • DOI: 10.22270/ijdra.v14i2.921

• Comparative Analysis of Cosmetic Labelling Requirements in the United States and Japan

  • Author: Vaishnavi Ramesh Khandomalke, Archana Yelmate, Kranti Satpute, Prakash Honrao
  • DOI: 10.22270/ijdra.v14i2.894