Vol. 8, Issue 1 (2019)

Author(s):
Neha Sharma

Abstract:
Regulatory affairs in the pharmaceutical sector constitute a critical framework governing the development, manufacture, and distribution of medicinal products. This paper presents a thorough examination of the multifaceted dimensions of regulatory affairs, elucidating its pivotal role in ensuring product safety, efficacy, and compliance with statutory requirements. Through a systematic review of literature, this research dissects the intricate interplay between regulatory bodies, industry stakeholders, and evolving legislative frameworks, shedding light on the dynamic nature of pharmaceutical regulation. Key areas of focus include the regulatory approval process, post-market surveillance, pharmacovigilance, and emerging trends shaping the regulatory landscape. By exploring global perspectives and case studies, this study not only underscores the significance of regulatory affairs in safeguarding public health but also delineates strategies for enhancing regulatory efficiency and adaptability in an era of rapid technological advancements and globalization. Ultimately, this research aims to provide a comprehensive understanding of regulatory affairs in pharmaceuticals, offering insights crucial for policymakers, industry professionals, and academia alike.