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Abstract

The journey from drug development to market approval is a labyrinthine process, with drug registration standing as a pivotal point. This article provides an in-depth exploration of the complexities faced behind the scenes of drug registration, unraveling the regulatory challenges encountered by pharmaceutical companies. From stringent documentation requirements to navigating international regulations and addressing evolving standards, the article delves into the intricacies of this critical phase in the drug development lifecycle. Strategies for overcoming these challenges are also discussed, emphasizing the importance of early engagement with regulatory authorities, technological integration, cross-functional collaboration, and continuous education. Understanding and addressing these regulatory challenges are imperative for ensuring the successful and compliant registration of new drugs