Published in:
Research Gate: Pharmaceutical Science
The Research Gate: Pharmaceutical Science provides a resource content dealing with the Pharmaceutical industry starting from drug discovery process to drug distribution system to patients.
The Research Gate: Pharmaceutical Science aims to publish all the recent and exceptional research articles and reviews in all areas of modern Pharmaceutical industry like drug discovery including in-silico drug design, combinatorial chemistry, new drug targets, Bioinformatics and chemoinformatics, Genomics and proteomics, medicinal chemistry, SAR, high-throughput screening, advances in ADME, drug delivery and Biopharmaceuticals, phytochemistry and pharmacognosy.
Open Access
Review Article
AI Review
Navigating Regulatory Challenges: A Comparative Exploration of Regulatory Missteps in Pharma"
Regulatory compliance
pharmaceutical industry
case study analysis
risk management
Abstract
This article explores global regulatory challenges in the pharmaceutical industry using a comparative case study approach. It examines incidents involving pricing violations, product recalls, and regulatory enforcement across different regions, identifying key patterns of non-compliance and operational gaps. The analysis highlights common issues such as inadequate quality systems, poor documentation practices, and lack of regulatory preparedness. Emphasis is placed on building a culture of compliance, ensuring patient safety, and implementing proactive risk management strategies .By drawing practical insights from real-world events, the article offers guidance for regulatory professionals, quality assurance teams, and decision-makers aiming to strengthen compliance frameworks and navigate the evolving global landscape of pharmaceutical regulation.