the need for complex data management systems, and the ongoing evolution of regulatory landscapes. Integrating novel ...
Scientific inquiry is unpredictable, and the data collected today might need to answer unforeseen questions tomorrow. Rigid ...
Successful MDSAP certification confirms compliance with Health Canada and U.S. FDA quality management system requirements, replacing FDA audit and inspection if required Health Canada and U.S. FDA ...
ticagrelor – a major unmet medical need in heart attack patients requiring surgery Successful MDSAP certification confirms compliance with Health Canada and U.S. FDA quality management system ...
The RNS System Post-Approval Study (PAS) is the largest prospective post-approval study in neuromodulation for patients with drug-resistant focal ...
The Canadian MDL application follows the Company's DrugSorb-ATR U.S. Food and Drug Administration ... manufacturer compliance of its quality management system with the standard and regulatory ...