When it comes to FDA regulated industries, competition is fierce, and stakes are high.

Compliance may sometimes be viewed as a “necessary evil,” potentially slowing production and requiring significant effort. If regulations are not adequately met, non-compliance can be costly, resulting in actions and penalties with ranges of up to $500 million and risking an organization’s market share, reputational costs and shareholder value.
 
On the other hand, the right compliance program doesn’t focus simply on developing practices to avoid penalties; rather, it can offer a strategic advantage in bringing quality products to market faster and within budget.
 
This paper offers practical strategies that manufacturers of FDA-regulated products can deploy to not only stay compliant but also provide its organization with a competitive edge.
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