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International Journal Of Drug Regulatory Affairs
Year 2024, Volume-12, Issue-1 (March)
Print ISSN : 2321-7162
Online ISSN : 2321-6794

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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

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