Pharmaceutical and clinical industry is the most regulated among all the industries. Every drug before getting market approval must undergo rigorous scrutiny and clinical trials to ensure its safety, efficacy and quality. These standards (regulations) are set by regulatory authorities of respective countries. Regulatory affairs [RA] is a department in the pharma industry. RA department is a crucial link between the company, its products and regulatory authorities. RA touches following studi...

World Health Organization is a specialised agency of United Nations, working with 194 Member States with a commitment to achieve better health for everyone, everywhere. The manufacturers of API, Formulation and quality control testing laboratories can participate in the program called Prequalification. It determines capacity of manufacturer to produce product of consistent quality in accordance with international standards & WHO specifications. WHO Prequalification program benefits popula...