Introduction: The FDA recently announced a proposal to change the current regulations for Investigational New Drug (IND) applications. The proposal includes two exemptions from IND... Read more
OTC Drug Monograph Application and the OTC New Drug Application (NDA) are the two processes through which every OTC Drug manufacturer or packager has to market drugs in the US market.
Whether you’re a domestic or foreign manufacturer or importer of OTC Drugs, you need to show evidence that you meet GMP requirements.
We'll prepare your application for establishment registration on behalf of your firm and submit it to FDA through the applicable ESG gateway.