In today's digital era, data security and compliance are more than just buzzwords—they are critical components of success for any organization, especially in sectors such as life sciences, pharmaceuticals, medical devices, and similar fields.
- November 30, 2023 Compliance, Audit and Validation, Regulatory Affairs, Regulatory Software & Services
- November 23, 2023 Food and Food Supplements
Businesses entering the food and dietary supplement market in Nigeria must be well-informed about the Regulatory environment in the country. With growing awareness of health and wellness among people, the demand for food and dietary supplements continues to grow globally.
- November 23, 2023 Pharmaceuticals, Compliance, Audit and Validation
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.
- November 23, 2023 Pharmaceuticals, Compliance, Audit and Validation
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.
- November 22, 2023 Pharmaceuticals, Regulatory Medical Writing
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.
- November 22, 2023 Pharmaceuticals, Regulatory Medical Writing
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.
- November 17, 2023 Pharmaceuticals, Regulatory Labeling
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.
- November 17, 2023 Pharmaceuticals, Regulatory 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.
- November 16, 2023 Pharmaceuticals, Regulatory Affairs
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.
- November 16, 2023 Pharmaceuticals, Regulatory Affairs
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.