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IntroductionThe U.S. Food and Drug Administration (FDA) has recently approved a ground-breaking gene therapy for the treatment of Aromatic L-amino Acid Decarboxylase (AADC) deficiency, marking a significant advancement in the field of genetic disorders. This approval is a beacon of […]
Each country has unique regulations and documentation requirements, making it essential to develop a comprehensive strategy to ensure compliance across various regions. Here are some key strategies and tools to streamline the global regulatory submissions process.
New ZLG Document on Transport Verification Published At the end of August, the German Central Authority of the Länder for Health Protection with regard to Medicinal Products and Medical Devices (Zentralstelle der Länder für Gesundheitsschutz bei Arzneimitteln und Medizinprodukten, ZLG) […]
DCTs are not a fad, but a trend that is transforming clinical research and patient care. By leveraging technology to make trials more accessible
Welcome to the latest edition of our Pharma News and Regulatory News Updates, where we bring you the most significant developments and breakthroughs in the pharmaceutical industry and the latest updates from regulatory agencies worldwide. These highlights from July 1st, […]
