Resources

A global manufacturer of pharmaceutical and medical devices needed to better integrate risk management throughout the product lifecycle.

With the Covid-19 pandemic now in check, we look back on how pharmaceutical manufacturers worldwide faced Emergency Use Authorization (EUA) problems to keep their supply chains intact. In this episode...

Background A Fortune 500 company received a Warning Letter from the FDA citing findings of device adulteration and misbranding, along with potential regulatory actions including product seizure, injunction, and civil...

With the Covid-19 pandemic sweeping the globe, manufacturers in the United States and around the world are facing problems keeping their supply chains intact. In this episode of RCA Radio,...

From the legalization of recreational marijuana to the growing popularity of CBD-infused products, the cannabis industry is all abuzz in the United States. What does Cannabis regulation look like? In...

Background A large medical device manufacturer received a critical warning from its Notified Body: unless significant deficiencies in its Medical Device Directive (MDD) technical files were corrected promptly, the company’s...