Packaging with purpose.

You decide on your medical device packaging and are ready to launch to market, but you discover you have forgotten a key part of getting your device launch – packaging validation. Depending on your timeline, this could be a major roadblock for your product...

What is happening with FDA Title II Drug Supply Chain Security Act (DSCSA)?

In October 2014, the FDA issued draft guidance in response to Title II (a/k/a the DSCSA) of the Drug Quality and Security Act (DQSA) of 2013. The requirements and compliance deadlines...

"The benefit of machine-intelligence technology is risk mitigation." - Kent Hevenor

It is no secret that heat sealing has been a perennial mainstay in the process of medical device and pharmaceutical product development. Rapid technology advancements are...