Practice Focus

Keith Korenchuk counsels and advises pharmaceutical, life sciences, medical device, biotechnology, and specialty pharmacy companies on regulatory and compliance matters worldwide.

Mr. Korenchuk provides regulatory and compliance guidance, advice, and solutions regarding:

• Regulatory matters involving healthcare professionals, including fraud and abuse, off-label promotion, False Claims Act, and transparency related issues
• Global anti-bribery legislation, including the US Foreign Corrupt Practices Act, the Organization for Economic Co-operation and Development Anti-bribery Convention, and related national implementing legislation
• Internal and government initiated investigations
• Global, regional, and country specific codes of practice and conduct, including codes issued by Pharmaceutical Research and Manufacturers of America (PhRMA), AdvaMed, International Federation of Pharmaceutical Manufacturers & Associations (IFPMA), and Eucomed
• US and global compliance systems design, implementation, and ongoing assessment
• State and Federal legislation involving pharmaceutical and medical device marketing, transparency, and disclosure
• Enterprise-wide risk management systems and programs

His work spans many business functions, including research and development, global marketing, medical affairs, sales and marketing, strategic alliances/acquisitions, supply chain, manufacturing, government affairs, and procurement.

Since 2001, Mr. Korenchuk has been included in The Best Lawyers in America. He has developed, led, and implemented "hands-on" educational and healthcare programs in the developing world that provide healthcare services and pharmaceuticals, teachers, school supplies, library resources, and computers to indigenous communities in South America for the past 11 years.

Prior Business Experience

Mr. Korenchuk's prior experience includes serving as the CEO of a company that focused on pharmaceutical and healthcare sector compliance, as well as the CEO of a research and development company that focused on homeland security technologies.

Representative Matters

• Assisting a global pharmaceutical company in implementing a revised worldwide compliance program, including program design and structure, code of conduct/policy revision, training, monitoring, auditing, and investigations processes.
• Providing assistance from a compliance perspective in conjunction with government investigations involving the Foreign Corrupt Practices Act, and development and implementation of related remediation plans.
• Providing assistance in negotiation of Corporate Integrity Agreements (CIAs) with the Office of the Inspector General (OIG) of the US Department of Health and Human Services, as well as ongoing support of CIA implementation, ongoing operation, and related OIG site visits.
• Evaluating regulatory issues and compliance effectiveness in discrete programs and activities, including advisory boards, speaker programs, consulting relationships, investigator sponsored trials, and customer relationship databases.
• Providing healthcare regulatory advice under the anti-kickback statute for pharmaceutical and medical device companies relating to healthcare professionals.
• Advising on the application of state marketing and disclosure laws to the operations of pharmaceutical and medical device companies.
• Assisting pharmaceutical and medical device companies in conducting overall program evaluations for subsidiaries in Europe, the Middle East, Latin America, and Asia, and assisting in remediation efforts.
• Advising on compliance related issues in interactions with government officials and healthcare professionals on a worldwide basis, including consideration of issues in China, Brazil, Russia, Argentina, Poland, India, Mexico, Philippines, Columbia, Greece, Germany, Italy, Vietnam and the United Kingdom.
• Advising the Board of Directors of a global pharmaceutical and healthcare company on compliance program effectiveness and related governance issues.
• Evaluating the compliance infrastructure of the research and development division of a pharmaceutical company, making recommendations to enhance the compliance infrastructure, and assisting in the implementation of compliance program enhancements.
• Assisting pharmaceutical, medical device, and health products companies evaluate and enhance their worldwide due diligence and ongoing compliance oversight of third party agents and distributors.
• Assisting a medical device company in evaluating its US and global programs, as well as providing implementation advice and assistance.
• Providing assistance in the conduct of an internal investigation regarding the operation of a medical affairs function.
• Evaluating the sales and marketing function of a newly acquired business unit for a pharmaceutical company and providing post-closing remediation recommendations and assistance.
• Providing assistance to a global medical device company on compliance governance, program structure, and training programs.
• Assisting companies in the analysis and implementation of business process and compliance changes required by the revised PhRMA, AdvaMed, IFPMA, and Eucomed Codes.