A ReviewonRegulatory Affairs in Pharmaceutical Industry

Abstract

The pharmaceutical industry is one of the most heavily regulated industries on the planet. RegulatoryGoverning Bodies (Authorities) have been formed all around the globe to ensure that medicines for human use satisfy global standards of Quality, effectiveness, and safety. For example, FDA, TGA, CDSCO, EMEA, and others. The role of regulatory affairs is to design and implement regulatory strategies to ensure that the drug development team’s combined efforts result in a product that is approved by regulatory bodies. Drug regulatory affairs is a dynamic subject that encompasses both scientific and legal elements of drug research, such as NDA, INDA, and ANDA. By following SOPs, ICH standards, and WHO – GMP guidelines, regulatory affairs experts assist the firm in avoiding problems like as poorly kept records, poor data presentation, and incorrect scientific thinking