Technology transfer aims to commercialize products successfully at your contract manufacturing organization (CMO) partner site. This means the manufacturing, analytics, packaging, relevant.
A pharmaceutical technology transfer or more commonly known as a tech transfer, is a series of knowledge transfers on a drug product and its established manufacturing processes from development to.
A feasibility study is a trial run that tests your manufacturing steps, materials, and equipment to confirm that your process is designed correctly. During a feasibility study, any differences in the.
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.
GxP is a general term used to describe the quality guidelines and regulations applied in the pharmaceutical industry. GxP is the abbreviation of “Good x Practice”. The “x” in GxP stands for the field.
For pharmaceutical product owners, to enhance their patients’ lives is their ultimate goal. Successful technology transfers ensuring product performance and safety before the product goes to market.
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.
