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So now you have a Warning Letter or worse, a Consent Decree and you need a strategy to move...

At a time when we must be efficient to remain competitive, it is important to set the correct...

It is important during an inspection to have a well-oiled strategy that has been honed and...

So, here we are amid a pandemic that the planet hasn’t witnessed the like of for a century! Not...

So, what are some of the things that we need to do to get ready for the next FDA inspection?First...

The FDA will look for entry points into your Quality Management System as a mechanism to highlight...

With the ever-increasing complexity of pharmaceutical supply chains, as more and more companies...

As the Corona virus continues to take hold of the world, what is the potential for this to affect...

……being well prepared is the most effective strategy for success! As previously mentioned,...

—-Be prepared, the FDA cometh! Preparing for the FDA is key and underpinning for success in...