Regulatory Affairs for clinical trials is the major part in the clinical trials approaches. Every clinical trial must be analyzed according to the Regulatory Affairs Guidelines. number of Regulatory Affairs departments will be there depending upon the countries within the ever-growing pace of companies. Global Harmonization in standards has led to a consistent approach in regulatory submissions
Quality Assurance plays a major role in the pharma industry for development of products and services in pharma and biotech, as part of GMPs (Good Manufacturing Practices). Quality Assurance refers to the step-by-step procedure of examining the drugs in pharma industry to meet specific quality, efficacy, and safety as per their intended use.