International Journal Of Drug Regulatory Affairs

Table of Contents

• REVIEW ARTICLE

  Nitrosamine contamination in pharmaceuticals: Regulatory perspectives and control strategies of USFDA, EMA & HC

  • Author: Nidhi Pardeshi, Vijay Satapara, Kajal Patel
  • DOI: 10.22270/ijdra.v12i1.624

• Regulatory requirement for medical devices

  • Author: Uthanthi Thamizhselvi Umapathi, Vijay Vijayakumar, Sivakumar Muthusamy, Vijayakumar Arumugam Ramamurthy, Deepa Natarajan
  • DOI: 10.22270/ijdra.v12i1.636

• Drug recalls: Trend analysis of Recalls by Indian Pharmaceutical Industry during the period 2013-2023

  • Author: Nikita Varshney, Vijay Bhalla, Manish Gupta
  • DOI: 10.22270/ijdra.v12i1.645

• Dosage form design: From concept to compliance - Navigating regulatory standards and patient needs

  • Author: Naushad Ahmed, Vivekanand Prajapati, Priyanka Mishra, N T Pramathesh Mishra
  • DOI: 10.22270/ijdra.v12i1.647

• The regulatory affairs automation tools used in the pharmaceutical industry: An overview

  • Author: Chandrasekaran Kumar, T M Pramod Kumar, V Balamuralidhara
  • DOI: 10.22270/ijdra.v12i1.649

• RESEARCH ARTICLE

  Analysis of the conditions for the creation of pharmaceutical university spin-offs within a public university in Burkina Faso

  • Author: Daniel Dori, Sonia Gampoa Nassouri, Siessima Lawakilia Natacha Tchaida Martine Toe Djiguimde, Raogo Ouedraogo, Rasmane Semde
  • DOI: 10.22270/ijdra.v12i1.651

• Quality of examination gloves in health facilities in Addis Ababa, Ethiopia

  • Author: Yisihak Abraham Mehari, Yemane Berhane, Heran Gerba Borta, Kidanemariam Gebre Michael
  • DOI: 10.22270/ijdra.v12i1.652

• REVIEW ARTICLE

  Technical reasons for delay and denial of regulatory approval of initial applications for (Abbreviated) new drugs filed by Indian Companies by USFDA, 2005-2022

  • Author: Nikita Varshney, Vijay Bhalla, Manish Kumar Gupta
  • DOI: 10.22270/ijdra.v12i1.653

• Overview of post-approval submissions management in US, Europe and Canada

  • Author: Charmi Patel, Richa Patel, Niranjan Kanaki, Vinit Movaliya, Shrikalp Deshpande, Maitreyi Zaveri
  • DOI: 10.22270/ijdra.v12i1.654

• Regulatory requirements for approval and registration procedure of biosimilar in US and European Union (EU)

  • Author: Nishi Patel, Hardik Prajapati, Navin Joshi, Vinit Movaliya, Niranjan Kanaki, Shrikalp Deshpande, Maitreyi Zaveri
  • DOI: 10.22270/ijdra.v12i1.655