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Pharmaceuticals are a highly regulated industry for good reason: the outsized impact medicines and treatments can have on the lives of patients. Regulatory scrutiny occurs across pharmaceutical operations, including sales and marketing, drug price reporting, patient privacy, clinical operations, medical device testing, and manufacturing. This makes pharma compliance one of the topmost priorities for companies. The ramifications of not complying with regulatory affairs in pharma can be serious, including significant financial judgments and even legal and criminal consequences.
Due to the risk of non-compliance and other threats to the pharamaseuticals company, drug developers should thoroughly understand what regulatory bodies govern them, be aware of new guidance and how it applies to them, and prioritize regulatory compliance at an enterprise level.
