The US FDA defines an OTC (Over the Counter) drug product as a non-prescription drug that can be marketed and used directly by consumers without having a prescription for a healthcare professional. FDA classifies OTC drugs into two categories, OTC monograph drugs and new OTC drugs. OTC monograph drugs do not require FDA pre-approval before being marketed in USA.

About Global Regulatory Partners Inc:

Global Regulatory Partners Inc, (GRP) is an American company that provides regulatory affairs, clinical, quality and safety services to medical devices and pharmaceutical companies globally. GRP headquarters is located in Massachusetts USA and its main affiliates are located in China, Japan, Brazil, Mexico and South Korea GRP helps many life science companies register their products in different countries in compliance with local regulations.