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Financial Penalties in Regulatory Compliance.

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Bibliographische Detailangaben
Titel: Financial Penalties in Regulatory Compliance.
Autoren: Lakshmi, S. Durga1 sindhuseshapu2212@gmail.com, Raghava, D.2, Rao, K. Nageswara3, Sravani, P. Naga4
Quelle: Journal of Cardiovascular Disease Research (Journal of Cardiovascular Disease Research). 2025, Vol. 16 Issue 10, p128-137. 10p.
Schlagwörter: *REGULATORY compliance, *NONCOMPLIANCE, *GOVERNMENT agencies, *LOSS control, *QUALITY assurance, *FINES (Penalties), *PHARMACEUTICAL industry
Firma/Körperschaft: UNITED States. Food & Drug Administration
Abstract: Regulatory compliance is a cornerstone of the pharmaceutical industry, ensuring that drugs are developed, manufactured, and marketed in accordance with safety, efficacy, and quality standards. However, non-compliance with regulatory requirements often results in significant financial penalties, impacting not just the profitability but also the reputation of pharmaceutical companies. This project aims to analyze the landscape of financial penalties imposed for regulatory non-compliance across major global regulatory agencies such as the US FDA, EMA, CDSCO, and others. By studying key case examples, reasons for penalties, types of violations, and the financial consequences involved, this research will offer insights into patterns of noncompliance and their cost implications. The study also explores preventive strategies, risk mitigation plans, and the importance of a strong quality and compliance framework within pharmaceutical companies. [ABSTRACT FROM AUTHOR]
Datenbank: Academic Search Index
Beschreibung
Abstract:Regulatory compliance is a cornerstone of the pharmaceutical industry, ensuring that drugs are developed, manufactured, and marketed in accordance with safety, efficacy, and quality standards. However, non-compliance with regulatory requirements often results in significant financial penalties, impacting not just the profitability but also the reputation of pharmaceutical companies. This project aims to analyze the landscape of financial penalties imposed for regulatory non-compliance across major global regulatory agencies such as the US FDA, EMA, CDSCO, and others. By studying key case examples, reasons for penalties, types of violations, and the financial consequences involved, this research will offer insights into patterns of noncompliance and their cost implications. The study also explores preventive strategies, risk mitigation plans, and the importance of a strong quality and compliance framework within pharmaceutical companies. [ABSTRACT FROM AUTHOR]
ISSN:09753583