International Journal Of Drug Regulatory Affairs
Year 2024, Volume-12, Issue-1 (March)
Print ISSN : 2321-7162
Online ISSN : 2321-6794 Table of contents  RSS Feed Review Articles Nitrosamine contamination in pharmaceuticals: Regulatory perspectives and control strategies of USFDA, EMA & HC
Nidhi Pardeshi, Vijay Satapara, Kajal Patel Regulatory requirement for medical devices
Uthanthi Thamizhselvi Umapathi, Vijay Vijayakumar, Sivakumar Muthusamy, Vijayakumar Arumugam Ramamurthy, Deepa Natarajan Drug recalls: Trend analysis of Recalls by Indian Pharmaceutical Industry during the period 2013-2023
Nikita Varshney, Vijay Bhalla, Manish Gupta Dosage form design: From concept to compliance - Navigating regulatory standards and patient needs
Naushad Ahmed, Vivekanand Prajapati, Priyanka Mishra, N T Pramathesh Mishra The regulatory affairs automation tools used in the pharmaceutical industry: An overview
Chandrasekaran Kumar, T M Pramod Kumar, V Balamuralidhara Research Articles Analysis of the conditions for the creation of pharmaceutical university spin-offs within a public university in Burkina Faso
Daniel Dori, Sonia Gampoa Nassouri, Siessima Lawakilia Natacha Tchaida Martine Toe Djiguimde, Raogo Ouedraogo, Rasmane Semde Quality of examination gloves in health facilities in Addis Ababa, Ethiopia
Yisihak Abraham Mehari, Yemane Berhane, Heran Gerba Borta, Kidanemariam Gebre Michael Review Articles Technical reasons for delay and denial of regulatory approval of initial applications for (Abbreviated) new drugs filed by Indian Companies by USFDA, 2005-2022
Nikita Varshney, Vijay Bhalla, Manish Kumar Gupta Overview of post-approval submissions management in US, Europe and Canada
Charmi Patel, Richa Patel, Niranjan Kanaki, Vinit Movaliya, Shrikalp Deshpande, Maitreyi Zaveri Regulatory requirements for approval and registration procedure of biosimilar in US and European Union (EU)
Nishi Patel, Hardik Prajapati, Navin Joshi, Vinit Movaliya, Niranjan Kanaki, Shrikalp Deshpande, Maitreyi Zaveri Top |