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.
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.
Turning a promising drug candidate into a successful pharmaceutical product involves scaling-up the processes, developed in the research lab, in order that commercial supply can be achieved. The.
Many of the pharmaceutical companies we work with have questions about how to best scale-up the manufacturing process for their products. With the bright promise of ramping sales and distribution.
