Regulatory Technology (Regtech) Applications in Pharmaceutical Compliance: Innovations, Challenges, and Opportunities (Research Article)

Author(s): Omer Wasiq*

Abstract: As the pharmaceutical industry faces growing challenges in meeting regulatory expectations, regulatory technology is becoming more popular to improve compliance. This article explores the role RegTech applications can play in enhancing the monitoring, documentation, reporting and control of compliance activities throughout the pharmaceutical lifecycle. The process will involve a qualitative review and comparative case-study approach to evaluate the technologies including artificial intelligence, blockchain, cloud platforms, robotic process automation, predictive analytics and connected monitoring devices. The areas of focus of the investigation include automated compliance surveillance, data integrity, regulatory submissions, quality-risk management, pharmacovigilance and inspection readiness. Expected outcomes indicate the ability of RegTech to minimise manual error, speed up reporting, enable early warning of deviations and enable transparency in audit trails. But validation of the system, cyber security, interoperability, highly qualified staff and regulatory acceptance are crucial to successful implementation. The article provides a structured evaluation of the practical utility of RegTech and examines how more advanced, responsive, reliable and proactive pharmaceutical compliance systems can be created.

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