A Comparative Study on the Dossier Submission for Pharmaceutical Products: Global Review

Swathi J, Muthu Pranesh K, Pavithran T, Nivetha D, D Nagasamy Venkatesh, N Arun and Shanmugakumar Sd
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Swathi J: Department of Pharmaceutical Regulatory Affairs, JSS College of Pharmacy, JSS Academy of Higher Education & Research, Ooty – 643001, The Nilgiris, Tamil Nadu, India
Muthu Pranesh K: Department of Pharmaceutical Regulatory Affairs, JSS College of Pharmacy, JSS Academy of Higher Education & Research, Ooty – 643001, The Nilgiris, Tamil Nadu, India
Pavithran T: Department of Pharmaceutical Regulatory Affairs, JSS College of Pharmacy, JSS Academy of Higher Education & Research, Ooty – 643001, The Nilgiris, Tamil Nadu, India
Nivetha D: Department of Pharmaceutical Regulatory Affairs, JSS College of Pharmacy, JSS Academy of Higher Education & Research, Ooty – 643001, The Nilgiris, Tamil Nadu, India
D Nagasamy Venkatesh: Department of Pharmaceutics, JSS College of Pharmacy, JSS Academy of Higher Education & Research, Ooty – 643 001, The Nilgiris, Tamil Nadu, India
N Arun: Department of Pharmaceutics, JSS College of Pharmacy, JSS Academy of Higher Education & Research, Ooty – 643 001, The Nilgiris, Tamil Nadu, India
Shanmugakumar Sd: Jyothishmathi Institute of Pharmaceutical Sciences, Karim Nagar -505 001, Telangana, India

Biomedical Journal of Scientific & Technical Research, 2023, vol. 48, issue 1, 39059-39063

Abstract: The Dossier is a series of papers on various topics. The process of reviewing and analyzing the pharmaceutical product dossier, which has administrative, quality, non-clinical and clinical data. The Drug Regulatory Authority in a specific country regulates and authorizes this process and the process is known as New Drug Application in the United States of America, Marketing Authorization Application in the European Union and other countries simply as the Registration Dossier. For dossier preparation.

Keywords: Journals on Medical Drug and Therapeutics; Journals on Emergency Medicine; Physical Medicine and Rehabilitation; Journals on Infectious Diseases Addiction Science and Clinical Pathology; Open Access Clinical and Medical Journal; Journals on Biomedical Science; List of Open Access Medical Journal; Journals on Biomedical Engineering; Open Access Medical Journal; Biomedical Science Articles; Journal of Scientific and Technical Research (search for similar items in EconPapers)
Date: 2023
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Persistent link: https://EconPapers.repec.org/RePEc:abf:journl:v:48:y:2023:i:1:p:39059-39063

DOI: 10.26717/BJSTR.2023.48.007589

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