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From Our Blog
Why Are Feasibility Studies Important For Your Pharmaceutical Product?
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...
What Is The Difference Between Verification And Validation of Analytical Methods In The Pharmaceutical Industry?
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 results...
What You Need To Know About Manufacturing OTC Products
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,...