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.

EU Technical Files

EU Technical Files

A concept similar to the FDA’s Design History Files, the EU Technical File is a collection of documents related to ...
Product Testing of Cosmetics

Product Testing of Cosmetics

Cosmetics are a separate category under the Food and Drug Administration (FDA) different from medical devices or ...
Pharmaceutical QMS

Pharmaceutical QMS

A quality management system, QMS,  is a crucial requirement for any organization in the life sciences ...
Aseptic Technique

Aseptic Technique

Aseptic technique is the practice and procedures utilized to prevent contamination from pathogens. There are four ...
Drug Quality Testing

Drug Quality Testing

The approval of new and generic drugs and biologics requires compliance with the Food and Drug Administration ...
Risk Mitigation

Risk Mitigation

Whenever risk is identified whether it is part of a process or the design of a product, mitigation of the risk ...
COVID-19 Fraudulent Products

COVID-19 Fraudulent Products

It has been a wild past two years trying to figure out what products can mitigate, treat, diagnose or even cure ...
Microbiological Testing

Microbiological Testing

Many microbes are harmless to humans, but some can cause serious health problems. Microbes can spoil food, ...
Reporting Adverse Events

Reporting Adverse Events

Post-market surveillance is necessary for ensuring compliance as regulatory bodies have the authority to impose ...
Label Changes and the 510k

Label Changes and the 510k

Submitting a 510k for a medical device can be a long and confusing process. When a 510k is submitted the device ...
CE Marks under IVDR

CE Marks under IVDR

The COVID-19 pandemic has changed the world by disrupting global supply chains and impacting human health. This ...

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