Practical Knowledge of Regulatory Guidelines for E-Drug Marketing Applications Makes for Smooth Submissions.
Practical Knowledge of Regulatory Guidelines for E-Drug Marketing Applications Makes for Smooth Submissions.
1 PagesCASE STUDY REGULATORY AFFAIRS CASE STUDY - REGULATORY AFFAIRS 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. Several pharmaceutical companies, mainly in USA
