Author: Nigel J Smart PhD

—-Be prepared, the FDA cometh! In preparing for your facility audit, the FDA will spend up to 16...

So, when the FDA arrives at your facility, the inspection team will present their credentials,...

So, you’re going to have an FDA inspection? Why is this going to happen? Either you have a...

The biopharmaceutical industry has come a long way in the last 40 years since the cloning of...

As we talk and listen to clients and customer prospects about what areas trouble them the most, we...