The United States Food and Drug Administration (US FDA) released the highly anticipated revised Quality Management System Regulation (QMSR) in February 2024. The updated regulation serves as the new set of Good Manufacturing Practices (GMP) guidelines of the US FDA for medical devices, effectively replacing the previous set of Quality System Regulations (QSR).
- April 26, 2024 Medical Devices
- April 24, 2024 Publishing & Submissions
The journey of a new medicinal product from discovery to patient use is a complex one, requiring rigorous scientific evaluation and Regulatory approval. Regulatory Publishers play a crucial role in this process by preparing and submitting high-quality Regulatory documents to the relevant agencies.
- April 24, 2024 Pharmaceuticals, Publishing & Submissions
In the intricate world of pharmaceutical development and regulation, the role of regulatory submission professionals stands out as indispensable. These individuals serve as the guardians of compliance, the architects of documentation, and the liaisons between pharmaceutical companies and regulatory bodies.
- April 19, 2024 Food and Food Supplements
The French sports nutrition market is swiftly evolving due to changing consumer preferences and upcoming regulatory adjustments. This transformation brings forth opportunities and obstacles for industry stakeholders, from the surge of functional foods to the focus on sustainability and personalized taste experiences.
- April 19, 2024 Pharmaceuticals, Regulatory Affairs
The Therapeutic Goods Administration (TGA) serves as the central Regulatory authority for therapeutic goods in Australia, ensuring that all medicines, medical devices, biological products, and complementary medicines entering the market meet stringent standards of safety, quality, and efficacy.
- April 19, 2024 Pharmaceuticals, Regulatory Medical Writing
Introduction:
In the dynamic realm of pharmaceuticals, the integrity of bioavailability (BA) and bioequivalence (BE) studies serve as key players for successful drug development. These studies not only determine the efficacy and safety of new drug candidates but also play a pivotal role in securing Regulatory approval, particularly from the FDA.
- April 19, 2024 Pharmaceuticals, Regulatory Medical Writing
Introduction:
In the dynamic realm of pharmaceuticals, the European Medicines Agency (EMA) stands as a guardian of patient safety and efficacy. Its guidelines for Advanced Therapy Medicinal Products (ATMPs) by ensuring good clinical practice provide a robust framework to ensure that innovative therapies meet stringent quality and Regulatory standards.
- April 19, 2024 Regulatory Affairs
In the pharmaceutical and biotech sectors, Regulatory operations and intelligence stand as the bedrock for ensuring the safety and efficacy of medicinal products. With the ever-evolving industry nature, staying updated on Clinical Trial Regulations (CTR) and safety reporting requirements is crucial for successful product development.
- April 19, 2024 Regulatory Affairs
Post-authorization procedures are a pivotal phase in a medicinal product's lifecycle that requires meticulous attention to ensure sustained safety, efficacy, and quality as it reaches patients.
- April 19, 2024 Chemicals
In the field of chemical regulations, prioritizing public health and environmental protection is crucial. In South Korea, this commitment is demonstrated through the Act on the Registration and Evaluation of Chemicals, also known as Korea REACH.