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Operating Under Consent Decree

Managing a Life Sciences company through a major regulatory action


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Tarnished reputations, lost sales, massive fines and remediation expenses, cultural change and hostile working environments, diminished morale, legal disputes, employee retention and product shortages are common challenges faced by Life Sciences companies operating under Consent Decrees (CD). There is no aspect of the business that is unaffected, and the impacts can extend to customers and patients as well. It takes a broad-based effort to effectively address the concerns of regulatory agencies while simultaneously preparing the company to manage its current business as well as their mid- and long-term operations. The effort involved goes well beyond simply developing and executing a remediation plan and should consider the strategies and tactics to design and manage an organization that not only has to survive as the remediation efforts are underway, but also thrive in the future.

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As used in this document, “Deloitte” means Deloitte Consulting LLP a subsidiary of Deloitte LLP. Please see www.deloitte.com/us/about for a detailed description of the legal structure of Deloitte LLP and its subsidiaries. Certain services may not be available to attest clients under the rules and regulations of public accounting.

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