The life sciences industry is undergoing a seismic shift, with automation and artificial intelligence (AI) transforming the landscape of Regulatory affairs. As we look towards 2025, the integration of these technologies is not just a trend but a fundamental change in how companies approach compliance and drug development.
- March 18, 2024 Pharmaceuticals, Regulatory Affairs
- March 18, 2024 Pharmaceuticals, Regulatory Affairs
Falsified medicines pose a significant threat to public health, undermining trust in the healthcare system and jeopardizing patient well-being. Recognizing the gravity of this issue, the European Union (EU) has implemented a multifaceted strategy to combat the distribution and marketing of falsified medicinal products within its member states.
- March 18, 2024 Pharmacovigilance, Regulatory Medical Writing
In the realm of pharmacovigilance (PV), ensuring the safety of patients is paramount. Adverse events can occur despite rigorous testing and regulatory approval of pharmaceutical products. When such events happen, it's essential to delve deep into understanding the root causes behind them. This is where Root Cause Analysis (RCA) comes into play.
- March 18, 2024 Pharmacovigilance, Regulatory Medical Writing
The landscape of clinical trials is undergoing a significant transformation, driven by the advent of decentralized clinical trials (DCTs). These trials represent a paradigm shift from traditional site-centric models to more patient-centric approaches, leveraging digital tools and remote monitoring techniques to bring the trials directly to the patients.
- March 15, 2024 Pharmaceuticals, Regulatory Labeling
In recent years, the pharmaceutical industry has witnessed a significant transformation with smart labels in packaging. Smart labels, also known as electronic or intelligent labels, are equipped with advanced technologies that enable them to store and transmit data, providing a wide range of benefits for pharmaceutical companies and consumers.
- March 15, 2024 Pharmaceuticals, Regulatory Labeling
Clinical trials are essential for advancing medical research and bringing new treatments to patients. However, ensuring compliance with labeling regulations and prioritizing patient safety presents significant challenges for researchers and pharmaceutical companies.
- March 15, 2024 Cosmetics Regulatory Services, Regulatory Affairs
The Philippines cosmetic market is vibrant and rapidly growing, offering an extensive array of beauty and personal care products. To ensure consumer safety and product quality, the country has established a robust Regulatory framework. Understanding the cosmetic regulatory scenario in the Philippines is crucial for manufacturers, importers, and consumers.
- March 15, 2024 Cosmetics Regulatory Services, Regulatory Affairs
New Zealand's cosmetic industry is dynamic, offering a wide range of beauty and personal care products to consumers. To ensure consumer safety and product efficacy, robust regulations and standards are in place. Understanding the cosmetic Regulatory scenario in New Zealand is essential for manufacturers, importers, and consumers.
- March 15, 2024 Pharmaceuticals, Regulatory Affairs
The Chinese pharmaceutical landscape is constantly evolving, with new regulations and drugs emerging regularly. While keeping up with these changes can be challenging, remaining updated is crucial for businesses operating in the Chinese market.
Here, we bring you five (05) of the most important pharmaceutical Regulatory updates in China that have been released in 2024.
- March 15, 2024 Cosmetics Regulatory Services, Regulatory Labeling
Cosmetic products are integral to our daily routines, and their safety relies heavily on accurate labeling. In Mexico, there are specific regulations in place to govern the labeling of cosmetics. Understanding these regulations is essential for manufacturers and importers to ensure compliance and provide consumers with accurate information.