Regulatory Compliance in the United States: A Comprehensive Analysis of USFDA Guidelines and Implementation Strategies
Akash Sharma *
KAULMED Private Limited, Sonipat, Haryana-131028, India.
Vriti Gamta
KAULMED Private Limited, Sonipat, Haryana-131028, India.
Gaurav Luthra
KAULMED Private Limited, Sonipat, Haryana-131028, India.
*Author to whom correspondence should be addressed.
Abstract
This research paper aims to provide a comprehensive analysis of regulatory compliance in the United States, with a specific focus on the guidelines set forth by the United States Food and Drug Administration (USFDA). Regulatory compliance plays a crucial role in ensuring the safety and efficacy of pharmaceutical products, medical devices, and food and beverages in the US market. This paper discusses the regulatory framework, key requirements, challenges faced by companies, and effective implementation strategies to achieve and maintain compliance with USFDA regulations. The findings of this research provide valuable insights for businesses operating in regulated industries and contribute to the understanding of the importance of regulatory compliance in the US.
Keywords: Regulatory compliance, USFDA, guidelines, implementation strategies, pharmaceuticals, medical devices, food and beverages