The pharmaceutical industry is at the forefront of technological advancements, research breakthroughs, and innovative drug development. In this rapidly evolving landscape, maintaining pharmaceutical compliance is paramount to ensure patient safety, Regulatory adherence, and the integrity of the industry.

In the pharmaceutical industry, ensuring patient safety is of paramount importance. With the rise in counterfeit drugs and the need for traceability, compliance and serialization have become critical aspects of pharmaceutical operations. Compliance refers to adhering to Regulatory requirements, while serialization involves assigning a unique identifier to each product unit.

Introduction

In the pharmaceutical arena, post-marketing surveillance PMS) plays a fundamental role in monitoring adverse effects and ensuring public health. Additionally, owing to the current data-driven world our blog explores the application of Quantitative Structure-Activity Relationship (QSAR) in post-marketing safety surveillance, with a specific focus on the role of regulatory vendors.

Introduction

In European Union's (EU) Clinical Trial Regulation (CTR) emerges as a transformative force, reshaping life sciences companies' approach and conduction of clinical trials. Clinical Trial Regulation aims to streamline and harmonize the regulatory processes governing clinical trials across EU member states.

In today's globalized world, the accessibility and availability of essential medications are crucial for the well-being of individuals across different regions. However, one significant challenge that hinders drug accessibility is pharma-regional labeling.

Global clinical trials are crucial in advancing medical research and bringing innovative treatments to patients worldwide. However, conducting trials across multiple countries and regions presents unique challenges, particularly labeling requirements. In this blog post, we will explore the labeling challenges faced by sponsors and researchers in global clinical trials and discuss strategies to navigate them effectively.

Introduction

Precision medicine stands at the forefront promising personalized and targeted treatments based on an individual's unique genetic makeup. As life sciences companies venture into the development of precision medicinal products, the regulatory landscape presents a complex terrain that demands strategic navigation.

In recent times, the emergence of nitrosamine impurities in certain generic drug substances has prompted a re-evaluation of industry practices. This blog takes a deep dive into the multifaceted world of nitrosamine mitigation, specifically in the context of generic drug products. Moreover, it also throws light upon considerations made for Nitrosamine Drug Substance Related Impurities.

Cosmetic products are regulated so that they are safe for regular/repeated use and efficacious as claimed or presumed. Historically, cosmetics were supposed to be a blend of overtly safe ingredients with an onus of safety lying majorly with the industry.

The Modernization of Cosmetics Regulation Act 2022 (MoCRA) represents a pivotal moment in the US FDA's authority over the cosmetics industry, marking a significant update to the regulations established in the Federal Food, Drug, and Cosmetic (FD&C) Act of 1938. Among the array of new requirements introduced by MoCRA, adverse event reporting stands out as a critical component.