Pharmaceutical Regulatory Affairs: Open Access

Department of Pharmaceutical Regulatory Affairs, Zurich University of Applied Sciences, Winterthur, Switzerland

Publications

• Opinion   
  Navigating the Complex World of Pharmaceutical Regulatory Affairs
  Author(s): Thomas Segura*
  
  The pharmaceutical industry operates in a highly regulated environment, where adherence to various regulatory requirements is essential to ensure the safety, efficacy, and quality of drugs. Regulatory Affairs (RA) professionals play a crucial role in navigating the complex landscape of pharmaceutical regulations, which are subject to continuous evolution. This article provides an overview of the key aspects of pharmaceutical regulatory affairs, including drug development, regulatory submissions, clinical trials, post-marketing surveillance, and global harmonization efforts. It explores the challenges faced by regulatory affairs professionals and highlights strategies to effectively manage compliance and ensure successful regulatory outcomes. The primary objective of pharmaceutical regulatory affairs is to safeguard public health by ensuring that pharmaceutical p.. Read More»
  DOI: 10.37421/2167-7689.2024.13.400

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