Abstract

THE ROLE OF REGULATORY AFFAIRS IN DRUG DEVELOPMENT AND CLINICAL TRIALS

Md. Sabeelkhan Patel*, Suryakant Das Kumar, Uzma Ayesha, Musab Ismail, Mohamed Rabie

ABSTRACT

The pharmaceutical industry is instrumental in developing life-changing medications, but the journey from conception to patient use is complex and regulated. Regulatory affairs professionals play a crucial role in ensuring the safety, efficacy, and compliance of drugs throughout development and clinical trials. They collaborate with researchers and stakeholders to navigate the stringent regulatory landscape and meet international standards. This article explores the essential functions of regulatory affairs in preclinical research, clinical trials, patient safety, regulatory compliance, and global harmonization. It also highlights the future trends shaping the field, such as real-world evidence, digital health technologies, and precision medicine.

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