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This blog will explore what eSTAR entails and its implications for the medical device industry.
One such mechanism for addressing safety concerns is the FDA recall process.
Two critical concepts in this realm are medical device rework and nonconformance. While they might seem similar at ...
Biostatistical methods play a pivotal role in guiding the design, analysis, and interpretation of clinical trial ...
In this blog, we delve into the intricacies of FDA OTC Monographs, shedding light on their purpose, structure, and ...
In this blog, we delve into the intricacies of designing pharmacology studies, exploring key considerations, best ...
. Any deviation from regulatory standards not only jeopardizes product quality and patient safety but also exposes ...
This blog will delve into the crucial role that internal audits play in safeguarding quality, enhancing ...
This blog will delve into the essential steps and considerations for conducting process validation for FDA ...
When the gears of governance grind to a halt during a government shutdown, the repercussions resonate far beyond ...
Central to GMP compliance is the concept of data integrity, a foundational principle that underpins the ...
The history of 21 CFR 820 traces back to the early 20th century when concerns over the safety and efficacy of ...
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