stdClass Object
(
    [id] => 18310
    [paper_index] => 202512-01-025187
    [title] => DETAIL REVIEW ON DRUG REGULATORY AFFAIRS 
    [description] => 
    [author] => Shreyash G. Sallawar, Dr.Sunil S.Jaybhaye, Mr.Kshitijkumar G.Wagh
    [googlescholar] => 
    [doi] => 
    [year] => 2025
    [month] => December
    [volume] => 11
    [issue] => 12
    [file] => fm/jpanel/upload/2025/December/202512-01-025187.pdf
    [abstract] => Drug Regulatory Affairs (DRA) is a vital and multidisciplinary field within the pharmaceutical industry that ensures the safety, efficacy, and quality of medicinal products throughout their life cycle. It involves the systematic management of all regulatory requirements associated with the research, development, manufacturing, marketing authorization, and postmarketing activities of drugs. The primary objective of DRA is to safeguard public health by ensuring that pharmaceutical products meet the necessary scientific, ethical, and legal standards established by national and international regulatory authorities. Major agencies such as the United States Food and Drug Administration (USFDA), the European Medicines Agency (EMA), the Central Drugs Standard Control Organization (CDSCO) in India, and the World Health Organization (WHO) play key roles in regulating and monitoring these processes globally. 
Regulatory affairs professionals act as the interface between pharmaceutical companies and regulatory bodies, facilitating the preparation and submission of documents like Investigational New Drug (IND) applications, New Drug Applications (NDA), and Marketing Authorization Applications (MAA). They also ensure continuous compliance through postapproval activities such as pharmacovigilance, product variation submissions, and labelling updates. With the increasing globalization of the pharmaceutical market, harmonization of regulatory guidelines through organizations such as the International Council for Harmonisation (ICH) has become essential. Therefore, Drug Regulatory Affairs serves as the backbone of modern drug development, ensuring that safe, effective, and high-quality medicines reach patients worldwide. 

    [keywords] => 
    [doj] => 2025-12-05
    [hit] => 
    [status] => 
    [award_status] => P
    [orderr] => 12
    [journal_id] => 1
    [googlesearch_link] => 
    [edit_on] => 
    [is_status] => 1
    [journalname] => EPRA International Journal of Multidisciplinary Research (IJMR)
    [short_code] => IJMR
    [eissn] =>  2455-3662 (Online)
    [pissn] => - --
    [home_page_wrapper] => images/products_image/11.IJMR.png
)
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