Technology transfer aims to commercialize products successfully at your contract manufacturing organization (CMO) partner site. This means the manufacturing, analytics, packaging, relevant.
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.
In the most general terms, an over-the-counter (OTC) product can be described as a medicine available for self-medication that does not require a doctor’s prescription. Self-medication is a common.
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.
Understanding is the foundation of a successful outsourcing relationship. When it comes time to outsource a pharmaceutical project, the drug developer must share the results of their hard work and.
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.
After 1990, the pharmaceutical industry shifted due to increased R&D spending, changes in the health insurance system, and the competition from new drugs and ones that were going generic. This shift.
