Vol 13 No 3 (2025): VOLUME 13, ISSUE 3, 2025 | International Journal of Drug Regulatory Affairs

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Research

Functional Food Interventions for Mitigating Cardiovascular Risk Markers in Adults

Mos Najma Akter

Pages 52-60
- View pdf Abstract Download pdf DOI 10.22270/ijdra.v13i3.780
Remarkable facts when concluding contracts for the conduct of clinical trials for medical devices in Germany

Raees Ahmed

Pages 116-121
- View pdf Abstract Download pdf DOI 10.22270/ijdra.v13i3.803

Review

Understanding Clinical Investigation and preparation of Technical file for Continuous Positive Airway Pressure (CPAP) Medical Device

Vedant L. Dixit, Sahil S. Gupta, Milind J. Umekar , Vinita V. Kale

Pages 1-14
- View pdf Abstract Download pdf DOI 10.22270/ijdra.v13i3.761
A study on the US FDA Regulatory requirements for Stem Cell Based-Products

Abdul Mannan, Zuha Fatima, Mohammed Yamin Salman

Pages 15-23
- View pdf Abstract Download pdf DOI 10.22270/ijdra.v13i3.769
Navigating the Regulatory Maze: Compliance Strategies for GHK-Cu in the Global Cosmetic Industry

Luckyrajsinh Vaghela, Nrupesh Patel

Pages 27-37
- View pdf Abstract Download pdf DOI 10.22270/ijdra.v13i3.770
The Integration of Wearable Devices with mHealth Apps for Remote Patient Monitoring: A Literature Review

A.S.M Anas Ferdous, SK Shamiur Rahman

Pages 38-51
- View pdf Abstract Download pdf DOI 10.22270/ijdra.v13i3.778
Validation of Aseptic Process in Sterile Pharmaceutical Facility in accordance with ICH Guideline

Rushikesh Kadu, Amey Umaley, Rupesh Chavhan, Ajay Pise

Pages 61-67
- View pdf Abstract Download pdf DOI 10.22270/ijdra.v13i3.783
Pharmaceutical 3D Printing: A Promising Technology for creating customized Medications

Swapnil More

Pages 68-76
- View pdf Abstract Download pdf DOI 10.22270/ijdra.v13i3.786
The future of Regulatory Submissions: Transition to eCTD 4.0

Komal Nagar, Mamta Choudhary, Bharti Yadav, Shivali Rahi, Ashutosh Upadhayay

Pages 77-84
- View pdf Abstract Download pdf DOI 10.22270/ijdra.v13i3.788
Modernizing Good Clinical Practice: Key Insights and Impact of ICH E6(R3) Guideline

Akash Aher

Pages 85-94
- View pdf Abstract Download pdf DOI 10.22270/ijdra.v13i3.793
Drug Labelling Regulations in the USA, Europe, and India: An Overview

Pradnya L. Shinde, Kranti L. Satpute, Rohit R. Sarda, Sagar S. Gilda, Nirbhay B. Chalmale

Pages 95-102
- View pdf Abstract Download pdf DOI 10.22270/ijdra.v13i3.796
The Role of Contract Law in Shaping the Pharmaceutical Sector: A Legal Study

Arun Nanda, Sanju Nanda

Pages 103-115
- View pdf Abstract Download pdf DOI 10.22270/ijdra.v13i3.797