Executive leadership experience in the US FDA and in both generic and brand pharma means our company brings real world experience to the table. 

This type of experience can't be found in many companies.

Every company has issues, that's OK. It's what you do about those issues that counts. Our FDA experience, accompanied by private sector compliance experience can help you put the right remediation strategy in place. 

First, stay calm......it's time to step back, assess and reflect on the inspection experience and observations. Should you address the specific topic or should you go broader? We can help with this and help you with a thorough response. We've evaluated and acted upon numerous 483 and Warning Letter responses while at FDA. It's this type of experience that differentiates us from the competition. #gmp #pharmaceutical quality #consulting #483 response