Drug Regulatory Affairs: Review. Introduction to regulatory affairs

      Аннотация: Drug development to commercialization is highly regulated. Every drug before getting market approval must undergo rigorous scrutiny and clinical trials to ensure its safety, efficacy and quality. Regulatory department is crucial link between company, products and regulatory authorities. In today’s competitive environment the reduction of the time taken to reach the market is vital to a product’s and hence the company’s success. The proper conduct of its Regulatory Affairs activities is therefore of considerable economic significance for the company. The success of regulatory strategy is less dependent on the regulations than on how they are interpreted, applied, and communicated within companies and to outside constituents. Regulatory Affairs plays a crucial role in the pharmaceutical industry and is involved in all stages of drug development and also after drug approval and marketing. In this book provides basic information regarding Regulatory Affairs- it’s important in pharmaceutical industry, Responsibility of regulatory professions, list of various regulatory authorities and their regulations etc

Ключевые слова: Regulatory affairs