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One of the main reasons the Federal Food and Drug Administration issued warning letters to CBD ...

As 2021 has come to a close and companies are holding and finalizing their last management reviews, ...

Labeling for medical devices is under strict regulations. The requirements are dependent on the class ...

Developing a Design and Development Plan is a part of the design controls process required by the FDA ...

Manufacturers may find themselves without the resources and processes needed to effectively and efficiently ...

A Non-Conforming Material Report or NCMR is the standard way to report a material that does not meet the ...

On Friday, Proctor & Gamble announced a voluntary recall of several of their aerosol dry shampoo and ...

When registering a medical device with the FDA the type of product influences the method of pre-market ...

The idea behind the management review process is to take a step back from the day-to-day operating of ...

One of the more ambiguous parts of the Quality System Regulations, 21 CFR 820, is making judgments ...

Registering a new device with the FDA can be tricky. The first step is to choose what pathway to follow ...

A Quality Management System (QMS) is often designed well before a company starts the development of its ...
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