Patricia Santos-Serrao, RAC, MasterControl’s director of clinical and regulatory solutions for pharmaceutical, blood, and biologics, discusses the five clinical trends...
Global regulatory affairs and compliance expert David Dills provides a comprehensive overview of the evolution of medical device clinical trials regulations and explains...
To comply with regulatory requirements pertinent to clinical trials, every organization engaged in a clinical trial must manage and maintain all trial-related content, documents,...
For pharmaceutical and biologics companies, the path to a global product launch is full of obstacles that could result in delays to registrations, many of which can be avoided...
While the process for obtaining a device clearance or premarket approval (PMA) in the United States is not the same as applying for a Shonin in Japan or a CE mark in Europe,...