What is the best way to ensure a smooth technology transfer from one pharmaceutical manufacturing facility to another?
There are many benefits to using a pharmaceutical contract manufacturer (CMO). Many small to mid-sized pharmaceutical companies utilize them for developing their drugs when they don’t have their own.
What Is The Difference Between Verification And Validation of Analytical Methods In The Pharmaceutical Industry?
To submit a filing to the FDA, whether that be an NDA, ANDA, or 505(b)(2), a product owner must provide technical files containing a pharmaceutical product's chemistry, manufacturing, and control.