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In a historic move on Friday afternoon, the FDA granted the first Emergency Use Authorization (EUA) to Pfizer and ...
In this whitepaper, we will explore how to best utilize CAPAs in the medical device industry including best practices, common pitfalls, and how to avoid “death by CAPA”. This paper will also discuss the purpose and basic principles of CAPAs, as well as how the process has developed over time.
The European Commission published a new guidance document that clarifies certain requirements originally outlined ...
Nanotechnology is the science of understanding, inventing, and controlling objects which are built in the scales ...
No matter what your product is, at some point in your regulatory journey you will need to appropriately determine ...
If your medical device has contact with human tissue, it is a safe bet that you will be required to conduct ...
Health Canada released a notice for the stakeholders of the medical device and drug industry to help them ...
Biosimilars are biological products that are composed or produced in living systems such as yeast or bacteria. ...
December is HIV/AIDS Awareness Month, and given the state of our current global pandemic, now is a great time to ...
The FDA published 21 CFR Part 11 in 1997 to regulate electronic records and electronic signatures. Technology has ...
Cloud Computing is speeding up the way we create, share, and view data. With features such as multiple backups, ...
If you have ever wondered exactly what role the FDA has in mammography and breast cancer screening, you are not ...
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