Before revision: Pharmaceuticals industry Regulatory submissions in the pharmaceutical–biotechnology and medical device industry comprise documents and data that are submitted to a regulatory agency to gain approval to market new drugs, biologics and devices .
After revision: but also when modifications are introduced in registered data (variations)Pharmaceuticals industry Regulatory submissions in the pharmaceutical–biotechnology and medical device industry comprise documents and data that are submitted to a regulatory agency to gain approval to market new drugs, biologics and devices .