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Find the latest content and resources from our team of experts to keep you in the know for all things quality and regulatory in the life science industry.
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In this blog, we'll delve into the key aspects of the FDA's proposed rule on lab developed tests and its potential ...
This blog explores the critical aspects of software validation, highlighting its significance in maintaining ...
This blog explores the critical aspects of software validation, highlighting its significance in maintaining ...
Within the European Union (EU), the regulation of combination medical device and drug products is meticulously ...
The journey from a novel drug or medical device's conception to its market approval is a meticulous process guided ...
Clinical trials are the backbone of medical research, providing the evidence necessary for the approval of new ...
In this blog, we will delve into the significance of the FDA RFD process, its key elements, and how it facilitates ...
In this blog, we will explore the significance of ISO 16949 certification, its key components, and how it ...
In this blog, we will explore the FDA's role in regulating compounding pharmacies, the challenges they face, and ...
In this blog, we will delve into the intricacies of the BLA process, exploring its significance, key components, ...
This blog will provide an overview of the mechanics behind reporting adverse events to the FDA.
In this blog, we will delve into the significance of INAD applications, their purpose, and the steps involved in ...
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