Eurofins Medical Device Services North America, part of a global network of over 20 medical device testing laboratories and a ...

Annex 22 marks a paradigm shift in pharmaceutical manufacturing, not only because it closes the longstanding “AI grey zone” but because its scope fundamentally changes how organizations must recruit, ...

Establishing a lab in biopharmaceutical fields such as cell and gene therapies can be demanding, requiring swift and efficient setup while meeting rigorous regulatory standards. The FDA's Good ...

In the pharmaceutical industry, cleanrooms are categorized based on the level of airborne particle concentration necessary to meet the cleanliness standards required for the specific manufacturing ...

Manufacturers are usually subjected to a diverse variety of regulations typically established by international and regional bodies. Failure to comply can result in the loss of authorization and ...