It is challenging for medical writers to ensure that their project’s content, style, and format are high quality. Even the best medical writers may make a mistake. Therefore, it is important to have a quality check of the documents. Quality Control (QC) experts look at a document with a set of “fresh eyes,” which can identify mistakes that an author might overlook. Hence, QC reviews are critical to Regulatory documents.
The term “regulatory compliance” takes on different definitions depending on the industry it is being applied to. But from an elevated level, compliance is all about incorporating requisite standards that conform to certain requirements and in relation to Regulatory it is nothing but a set of regulations that any given organization must follow to meet specific requirements. Failing to do so, organizations must pay the cost of non-compliance. If we take the case of the US pharmaceutical industry alone, 74 settlements were made towards penalties worth of 10.2 billion dollars in two years.