International Journal Of Drug Regulatory Affairs

Table of Contents

• REVIEW ARTICLE

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

  • Author: Vedant L. Dixit, Sahil S. Gupta, Milind J. Umekar, Vinita V. Kale
  • DOI: 10.22270/ijdra.v13i3.761

• A study on the US FDA Regulatory requirements for Stem Cell Based-Products

  • Author: Abdul Mannan, Zuha Fatima, Mohammed Yamin Salman
  • DOI: 10.22270/ijdra.v13i3.769

• Navigating the Regulatory Maze: Compliance Strategies for GHK-Cu in the Global Cosmetic Industry

  • Author: Luckyrajsinh Vaghela, Nrupesh Patel
  • DOI: 10.22270/ijdra.v13i3.770

• The Integration of Wearable Devices with mHealth Apps for Remote Patient Monitoring: A Literature Review

  • Author: A.S.M Anas Ferdous, SK Shamiur Rahman
  • DOI: 10.22270/ijdra.v13i3.778

• RESEARCH ARTICLE

  Functional Food Interventions for Mitigating Cardiovascular Risk Markers in Adults

  • Author: Mos Najma Akter
  • DOI: 10.22270/ijdra.v13i3.780

• REVIEW ARTICLE

  Validation of Aseptic Process in Sterile Pharmaceutical Facility in accordance with ICH Guideline

  • Author: Rushikesh Kadu, Amey Umaley, Rupesh Chavhan, Ajay Pise
  • DOI: 10.22270/ijdra.v13i3.783

• Pharmaceutical 3D Printing: A Promising Technology for creating customized Medications

  • Author: Swapnil M More
  • DOI: 10.22270/ijdra.v13i3.786

• The future of Regulatory Submissions: Transition to eCTD 4.0

  • Author: Komal Nagar, Mamta Choudhary, Bharti Yadav, Shivali Rahi, Ashutosh Upadhayay
  • DOI: 10.22270/ijdra.v13i3.788

• Modernizing Good Clinical Practice: Key Insights and Impact of ICH E6(R3) Guideline

  • Author: Akash Aher
  • DOI: 10.22270/ijdra.v13i3.793

• Drug Labelling Regulations in the USA, Europe, and India: An Overview

  • Author: Pradnya L. Shinde, Kranti L. Satpute, Rohit R. Sarda, Sagar S. Gilda, Nirbhay B. Chalmale
  • DOI: 10.22270/ijdra.v13i3.796

• The Role of Contract Law in Shaping the Pharmaceutical Sector: A Legal Study

  • Author: Sanju Nanda, Arun Nanda
  • DOI: 10.22270/ijdra.v13i3.797

• RESEARCH ARTICLE

  Remarkable facts when concluding contracts for the conduct of clinical trials for medical devices in Germany

  • Author: Raees Ahmed, Paula Hasselmann, Christoph Gerst
  • DOI: 10.22270/ijdra.v13i3.803