Monica R. Chmielewski, J.D., is a partner and health care and life sciences lawyer with Foley & Lardner LLP, and is co-chair of the firm’s Life Sciences Industry Team and vice chair of the firm's Health Care Industry Team. She focuses her practice solely in representing pharmaceutical and medical device companies, health care providers, and pharmacies in the area of health care, health care transactions, clinical research, supply chain, and food and drug law. Her practice involves counseling clients on all matters relating to compliance with regulations governing all aspects of clinical research, investigations of research misconduct, Institutional Review Board (IRB) issues, the conduct of U.S. and international clinical trials, government investigations and audits, pharmaceutical product promotion (including counsel on off-label promotion), 510K applications, the regulation of software as a medical device, mobile medical applications, Continuing Medical Education (CME), preparation of research contracts, grant contracts and administration, Pharmacy Benefit Managers (PBM) matters, good clinical practice (GCP) issues, customs import and export issues, hospital and physician issues, joint venture and other collaborative efforts, preparation and review of hospital, physician and other provider contracts, accountable care organization (ACO) formation and operation, HIPAA, physician recruitment, corporate compliance issues, medical staff and peer review, accreditation matters, and supply chain and procurement issues. She also participates as transactional counsel in numerous health care, industry and corporate transactions.
Monica R. Chmielewski