Regulatory strategy should be business strategy since all regulatory risks are business risks but not all business risks are regulatory risks. Mergers and acquisitions (M&A) (and divestitures) are a major cause for disrupting regulatory compliance framework. Often they tend to disrupt standardization, if one exists. Other causes are diversified portfolios, in multiple geographies, M&A from different geographies. This problem gets more complicated for medical devices for different classes of devices. The lack of standardization of QMS processes and other aspects lead to warning letters in some cases. While cost of compliance is high and comes with the territory for life sciences companies, price paid for non-compliance when found by an external agency is exorbitant and avoidable. So to contain/minimize the price of non-compliance, it is important to put enough effort, time and money up front during the due diligence process of mergers and acquisitions. This due diligence should identify the differences in processes and systems used to implement them and how post-merger the compliance is achieved.
Last date updated on May, 2021