A Simple Innovative Modification in the PharmacoVigilance Process Shows Great Improvement in Data Accuracy

A Simple Innovative Modification in the PharmacoVigilance Process Shows Great Improvement in Data Accuracy



QUALITY ASSURANCE STRATEGY

Introduction: The Clinical Quality Assurance has witnessed a dramatic rise in its impact and effectiveness in the drug development and clinical research. The first applications of quality assurance to the drug development , pre-clinical studies , and clinical research have been explored from the day of its infancy ,by a handful of drug pioneers. Quality assurance has been integrated with all the phases of clinical research and drug development.




Practical Knowledge of Regulatory Guidelines for E-Drug Marketing Applications Makes for Smooth Submissions.

One of our clients wanted to submit electronic Abbreviated New Drug Application (ANDA) to USA FDA, to get market approval for a generic drug. We prepared the entire ANDA in electronic Common Technical Document (eCTD) XML format.