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Abstract

This review paper provides a comprehensive analysis of the field of regulatory affairs, offering insights into its historical evolution, current challenges, emerging trends, and future directions. Regulatory affairs play a pivotal role across various industries in ensuring compliance with laws and regulations, maintaining product quality, and safeguarding public health and safety. Drug regulatory affairs are an important part of the pharmaceutical industry. As usual the pharmaceutical industry is growing very fast, and there is a need Regulatory affairs experts to meet current needs industry for global competition. Pharmaceutical drug regulatory affairs covers different registration parameter of pharmaceutical product. Various government agencies are involved in regulating drugs within their market, namely, USFDA-US, EDQM-Europe, TGA-Australia, MHRA-UK and TPD-Canada. Regulatory affairs ensures the Quality, Safety and efficacy of product.

Keywords

Regulatory Affairs, Quality Assurance, Compliance, Regulatory authority, Current challenges

Reference

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Kishor S. Arote
Corresponding author

Department of Pharmaceutical Quality Assurance, KVPS Institute of Pharmaceutical Education Boradi, Dhule 425428.

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Darshan A. Salade
Co-author

Department of Pharmaceutical Quality Assurance, KVPS Institute of Pharmaceutical Education Boradi, Dhule 425428.

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Nilesh V. Patil
Co-author

Department of Pharmaceutical Quality Assurance, KVPS Institute of Pharmaceutical Education Boradi, Dhule 425428.

Kishor S. Arote*, Darshan A. Salade, Nilesh V. Patil, A Brief Review on Regulatory Affairs: Ensuring Compliance, Safety, and Market Access , Int. J. in Pharm. Sci., 2023, Vol 1, Issue 10, 22-30. https://doi.org/10.5281/zenodo.8397986

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