Regulatory and enforcement actions can present significant challenges for a company’s day-to-day business operations and strategic planning efforts. Shook, Hardy & Bacon provides regulatory, compliance and risk management advice to a broad range of clients from emerging companies to some of the largest companies in the world.

Our attorneys counsel prescription and nonprescription drug, cosmetic, food and beverage, dietary supplement, medical device, and animal feed and drug manufacturers and retailers; we handle various enforcement and rulemaking proceedings in addition to assisting clients with regulatory matters.

Shook attorneys also advise on compliance in connection with the manufacture, sale and promotion of consumer products; clinical trials; approval pathways; labeling; safety; facility and product registration; facility inspections; custom holds; and product withdrawals and recalls.

We support clients in crisis management issues that arise from inspections, quality failures and recalls—including evaluating reporting obligations, responding to Form 483 findings and enforcement letters, and preparing media statements. We also offer our clients auditing and assessment of litigation risks and product liability considerations.

Shook attorneys regularly assist clients with issues involving: 

In addition, our attorneys engage in strategic influence initiatives to improve the business climate in which our clients operate; we also can assist clients in the event of governmental investigations.