The global race to bring new drugs and medical devices to market has fuelled the rise of parallel submissions – a strategy where companies file applications with Regulatory agencies in multiple countries concurrently. A recent study by Tufts Center for the Study of Drug Development found that parallel submissions for new drugs can reduce approval timelines by an average of 9 months.
- March 28, 2024 Publishing & Submissions, Regulatory Software & Services
- March 27, 2024 Pharmaceuticals, Regulatory Medical Writing
In the realm of pharmaceuticals, one of the critical aspects of ensuring safety is the implementation of child-resistant packaging (CRP). This blog post delves into the importance of CRP and its relevance to medical writing, a field that plays a significant role in communicating drug information effectively.
- March 27, 2024 Pharmaceuticals, Regulatory Medical Writing
Clinical trial transparency is an integral component of ethical research conduct and encompasses the dissemination of comprehensive trial details and results to a diverse array of stakeholders, including the public, patients, healthcare professionals, and researchers.
- March 18, 2024 Pharmaceuticals, Regulatory Affairs
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
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.