Vol 14 No 2 (2026): VOLUME 14, ISSUE 2, 2026 | International Journal of Drug Regulatory Affairs

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Research

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

Vijaya Ratna Jayanti, Sarveswara Rao Mandavilli, Heera Battu

Pages 60-75
- View pdf Abstract Download pdf DOI 10.22270/ijdra.v14i2.906

Review

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

Harsh Patel, Vinit Movaliya, Niranjan Kanaki, Maitreyi Zaveri, Rajnish Verma, Zuki Patel

Pages 1-3
- View pdf Abstract Download pdf DOI 10.22270/ijdra.v14i2.868
Comparative Analysis of Regulatory Approval Processes for Medical Devices in India and the European Union

Sarveshwar Jeevan Lokhande, Vaibhav Janak Yede, Nirbhay Baburao Chalmale, Rohit Ramnivas Sarda, Kranti Limbajirao Satpute, Sagar Suresh Gilda

Pages 4-11
- View pdf Abstract Download pdf DOI 10.22270/ijdra.v14i2.873
Automated Classification of Post-Approval Changes Using Regulatory Intelligence Models

Kiran Kumar Gande

Pages 12-19
- View pdf Abstract Download pdf DOI 10.22270/ijdra.v14i2.874
Regulatory Frameworks Governing Pharmaceutical Manufacturing Site Transfers: A Comparative Review of WHO, EMA, and US FDA Approaches

Immaculate Sherlin Sheridon Vaz, K Subalakshmi, S Ramesh

Pages 20-27
- View pdf Abstract Download pdf DOI 10.22270/ijdra.v14i2.875
Drug Safety of Antihypertensive Medicines Using Pharmacovigilance Data: Signal Management Through Traditional Methods Versus Process Automation

Yash Patel, Vinit Movaliya, Niranjan Kanaki, Zuki Patel, Mrugank Parmar, Maitreyi Zaveri

Pages 28-32
- View pdf Abstract Download pdf DOI 10.22270/ijdra.v14i2.880
A Comparative Study of Medical Device Regulatory Frameworks: India vs. the European Union

Amisha Patel, Niranjan Kanaki, Zuki Patel, Maitreyi Zaveri, Vinit Movaliya

Pages 33-37
- View pdf Abstract Download pdf DOI 10.22270/ijdra.v14i2.881
A Comparative Study of the Regulatory Landscape for Pre-filled Syringes (PFS) in the Philippines and Uganda

Bhumi Solanki, Maitreyi Zaveri, Zuki Patel, Vinit Movaliya, Rahul Nayak, Niranjan Kanaki

Pages 38-44
- View pdf Abstract Download pdf DOI 10.22270/ijdra.v14i2.883
Regulatory Lifecycle Management of Solid Oral Dosage Forms in Nigeria and Kenya

Shreya Kumar, Zuki Patel, Niranjan Kanaki, Maitreyi Zaveri, Shruti Kharidia, Vinit Movaliya

Pages 45-48
- View pdf Abstract Download pdf 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

Manasvi Kotadia, Vinit Movaliya, Niranjan Kanaki, Maitreyi Zaveri, Shailesh Khacharia, Zuki Patel

Pages 49-53
- View pdf Abstract Download pdf 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

Sharlee Krunalkumar Shah, Vinit Movaliya, Zuki Patel, Maitreyi Zaveri, Akshita Parekh, Niranjan Kanaki

Pages 54-59
- View pdf Abstract Download pdf DOI 10.22270/ijdra.v14i2.891
Overview of Structural Specifications and Validation of eCTD (v3.2.2): Elucidation of the General Architecture of EU Module 1 and GCC Module 1

Rabab Abdo Mohamed Fadlelmula

Pages 76-83
- View pdf Abstract Download pdf DOI 10.22270/ijdra.v14i2.914
Driving First‑Cycle ANDA Approvals Through Strategic Regulatory Planning

Piyush Modi, Jigneshkumar Modasiya, Dhaval Desai

Pages 84-89
- View pdf Abstract Download pdf DOI 10.22270/ijdra.v14i2.921
Comparative Analysis of Cosmetic Labelling Requirements in the United States and Japan

Vaishnavi Ramesh Khandomalke, Archana Yelmate, Kranti Satpute, Prakash Honrao

Pages 90-93
- View pdf Abstract Download pdf DOI 10.22270/ijdra.v14i2.894