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When an event occurs related to a medical device there is the need to determine if it qualifies as an adverse ...
In 1976, the Medical Device Amendments of the Federal Food, Drug, and Cosmetic Acts established three regulatory ...
There are many different types of Regulatory audits that can be conducted. These are audits that upon successful ...
A certificate of analysis (CoA) is a document that manufacturers create that verifies the products they ...
Quality is something that should be integrated into an organization. To pursue quality means to drive forward ...
Accelerated stability testing increases the rate of chemical degradation and physical change of a drug by using ...
In 2016 the Medical Device Single Audit Program (MDSAP) was initiated. Having a global approach to monitoring and ...
A concept similar to the FDA’s Design History Files, the EU Technical File is a collection of documents related to ...
Cosmetics are a separate category under the Food and Drug Administration (FDA) different from medical devices or ...
A quality management system, QMS, is a crucial requirement for any organization in the life sciences ...
Aseptic technique is the practice and procedures utilized to prevent contamination from pathogens. There are four ...
The approval of new and generic drugs and biologics requires compliance with the Food and Drug Administration ...
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