Hygenix Blog

Many life sciences projects do not stall because of the wrong strategy. They stall because no one clearly owns the…

A pharmaceutical facility can be on schedule, under construction, and moving through major project milestones while…

The facility is built. The cleanroom is classified. The equipment is installed. And the project is still months…

A written 483 response may be "the primary or a key component" in FDA's evaluation of whether subsequent Agency…

Qualified vendors don’t always lose because of price, scope, or technical ability. Often, they lose momentum…

By the time a bid is issued, buyers have usually already formed a view of which vendors look credible enough to…

FDA’s Manufacturing PreCheck Pilot Program has moved from concept to an active intake and selection process.…