Resource Center

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.

The IND Process: An Overview

The IND Process: An Overview

Prior to drugs being commercially available, manufacturers often conduct pre-clinical studies to obtain data ...
GDP PRACTICES

GDP PRACTICES

Across all industries, documentation is a key aspect of maintaining good quality and traceability over products. ...
The 510K Process

The 510K Process

A 510(k) is a premarket submission made to the Food and Drug Administration (FDA) by medical device manufacturers ...
Quality Through Automation

Quality Through Automation

Whether looking to update an existing process or implement something brand new, process design is a critical ...
Equipment Validation

Equipment Validation

Accurate and precise measurements are vital in the pharmaceutical, medical device, and other FDA regulated ...

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