The journey of a drug from its conception to its entry into the global market is a complex and multifaceted process, fraught with challenges and governed by stringent regulations. Pharmacovigilance (PV) plays a critical role in this journey, ensuring that the safety and efficacy of pharmaceutical products are maintained at every stage.
- April 30, 2024 Pharmacovigilance, Regulatory Medical Writing
- April 30, 2024 Pharmaceuticals, Compliance, Audit and Validation
GxP stands for "Good Practices," and the "x" can be replaced with various letters to denote specific areas, such as Good Clinical Practice (GCP), Good Manufacturing Practice (GMP), Good Laboratory Practice (GLP), and Good Distribution Practice (GDP), among others.
- April 30, 2024 Pharmaceuticals, Compliance, Audit and Validation
In the dynamic landscape of pharmaceuticals, ensuring product quality, safety, and regulatory compliance is paramount. A robust network of suppliers and vendors plays a crucial role in this ecosystem. However, the challenge lies in ensuring these partners meet the necessary quality standards and adhere to regulatory requirements.
- April 26, 2024 Medical Devices
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 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.