Case Study

Quarterly compliance reviews under a federal corporate integrity agreement.

Quarterly compliance reviews under a federal corporate integrity agreement.

Pages 3 Pages

Quarterly compliance reviews under a federal corporate integrity agreement. Summary Client industry: Pharmaceutical Manufacturing Business Challenge: Complex substantive framework; reviews every three months Highlights/Outcome: Special Counsel has conducted nearly a dozen consecutive reviews; keeping our client compliant with the CIA while meeting timeframe and budgetary targets Opportunity Resolving allegations of improper marketing practices for FDA-approved proprietary medications, Special Counsel’s client, a global pharmaceutical manufacturer, entered a 2011 civil settlement with the U.S. Government alongside a Corporate Integrity Agreement (“CIA”). Pursuant to the CIA, the company must retain an independent review provider to conduct quarterly compliance reviews of its int

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