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Showing posts from December, 2022

Regulatory Compliance and Technology

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Regulatory compliance essentially means making sure that all processes and activities are in accordance with, relevant legislations, guidelines, laws, and standards. This is important in regulatory affairs to make sure that all processes involved in pharmaceutical development- from pre to post market stages- are adhere to requirements and standards that would ensure safety, efficacy, & quality and minimize patient risk. Regulatory compliance is priority for all pharma regulatory affairs organizations and in-house departments as non-compliance can not only lead to patient harm but also product recall and subsequent business loss. A business that can meet the standards and requirements that are set by regulatory authorities is also an aspect of regulatory compliance that is important, where certain operations, activities and even the organization’s employees are “in compliance” or not. It is also possible that an organization can be compliant with one set of regulations i.e., for