by shannon | Apr 1, 2021 | Articles
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 commercial production. It can also mean knowledge transfer about...
by shannon | Mar 11, 2021 | Articles
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 process resulting from the scale, materials, or equipment...
by shannon | Feb 18, 2021 | Articles
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 (CMC), safety (nonclinical), and efficacy (clinical) testing...
by shannon | Feb 4, 2021 | Articles
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 treatment of many routine health problems such as headaches, allergies,...
by shannon | Jan 21, 2021 | Articles
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 technical hurdles involved in making this transfer can be daunting. Also,...
