Author(s): Gayatri J Khanderao, Jitendra A Kubde, Pooja R Hatwar, Ravindra L Bakal and Vaishnavi G Karule

Abstract: The field of regulatory affairs (RA), sometimes referred to as government affairs, is relatively new and emerged from governments’ efforts to safeguard the public’s health by regulating the efficacy and safety of goods including pharmaceuticals, medical gadgets, agrochemicals, cosmetics, veterinary medications, insecticides and supplementary therapies. Drugs pharmaceutical product registration is the focus of regulatory affairs. Every rule and regulation related to product filing are compiled in this assessment. The entire CTD and eCTD submission is covered in this paper. Procedure, as well as the accompanying modules. Additionally, it highlights the major regulatory organizations worldwide. There is discussion of ROW market trends, clinical trials, R&D, regulatory affairs in product management and the US drug approval processes.

DOI: 10.22271/27889246.2025.v5.i1c.120

Pages: 192-200 | Views: 105 | Downloads: 52

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