So, your new product is ready for the next step – commercial manufacturing production. You have decided not to invest in new equipment or building a new manufacturing line. You’re now looking 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.
We are often asked, “Why do we need Pharmaceutical Feasibility Studies?”. In the development of a new drug, it is important to note that a feasibility study is probably the single most important.
Oral solid dose (OSD) delivery remains the most popular route for administering drugs. Market forces are prompting pharmaceutical companies to pursue a broad array of OSD development strategies to.
