Foley & Lardner LLP: Monica R. Chmielewski

Within the "Nearby Lawyers" platform category, Foley & Lardner LLP's Chicago office, situated at 321 N Clark St Suite 3000, Chicago, IL 60654, USA, stands as a prominent legal hub, particularly for clients in specialized industries. This address places the firm within Chicago's bustling River North district, a dynamic area known for its mix of corporate offices, dining, and cultural attractions, offering convenient access for a diverse clientele. The environment of Foley & Lardner's Chicago office is designed to reflect its standing as a national law firm with global reach. It is a modern and sophisticated space, equipped with the technology and infrastructure necessary to support complex legal work and foster collaboration among its over 140 lawyers and legal professionals. The firm emphasizes a professional yet approachable culture, which is crucial when dealing with the intricate and often sensitive matters handled by their specialized practice groups.

A key attorney within Foley & Lardner LLP's Chicago office, and a distinguished figure in her field, is Monica R. Chmielewski. As a partner and Vice Chair of the firm's Health Care Practice Group, Ms. Chmielewski has dedicated her entire career to the representation of health care providers, pharmaceutical and medical device companies, and pharmacies. Her practice is exclusively focused on health care law, encompassing health care transactions, clinical research, supply chain issues, and food and drug law. This singular focus allows her to develop an exceptional depth of knowledge and expertise in a highly regulated and rapidly evolving sector.

The services offered by Monica R. Chmielewski are comprehensive and tailored to the unique needs of her health care and life sciences clients. She provides daily counsel to numerous health systems, hospitals, academic medical centers, pharmacies, and biotech, pharmaceutical, and medical device companies. Her expertise includes guiding clients through the complex web of regulatory compliance governing all aspects of clinical research, including investigations of research misconduct and Institutional Review Board (IRB) issues. She advises on the conduct of both U.S. and international clinical trials, ensuring adherence to the myriad of federal and state regulations. For local users in Chicago involved in the health care or life sciences industries, her guidance on these critical areas is invaluable for mitigating risks and ensuring compliant operations.

Furthermore, Ms. Chmielewski is highly active as transactional counsel in health care, life science, and corporate transactions. Her experience spans mergers, purchases and sales, or transfers of sponsorship of hospitals, pharmacies, contract research organizations (CROs), physician-owned surgery centers, and health systems. She possesses in-depth knowledge of federal and state regulation of the drug and device supply chain, advising entities, health care providers, investors, and lenders on transactional matters and regulatory compliance, including mergers and acquisitions, recapitalizations, buyouts, restructurings, joint ventures, and a broad range of commercial transactions. Her counsel extends to daily supply chain and materials management issues, group purchasing organization (GPO) negotiations and formation, and advising health plans on procurement and contracting with Pharmacy Benefit Managers (PBMs).

Monica also counsels health care entities, pharmaceutical and medical device companies, pharmacies, and laboratories regarding the operation and functions of their corporate compliance and integrity programs. This includes assisting with the composition and development of programs, as well as reviewing and assessing existing programs to ensure they meet the latest legal and Office of Inspector General requirements and standards. Her experience also covers specific compliance issues arising under critical statutes such as the False Claims Act (FCA), Stark Law, Anti-Kickback Statute, EMTALA, Civil Monetary Penalties Law, licensure/certification, and HIPAA. Additionally, she advises on regulatory and compliance issues presented by telemedicine and telehealth, including structuring and negotiating professional services agreements for telemedicine services and composing telemedicine policies and procedures.

The features that distinguish Foley & Lardner LLP, and Monica R. Chmielewski's practice, include its industry-focused approach and national platform. Foley & Lardner operates with a deep understanding of the sectors it serves, with health care and life sciences being a primary focus area. This specialized knowledge allows them to anticipate challenges and provide proactive, practical solutions. The firm prides itself on providing "sound business advice and developing innovative ideas," acting as "trusted business advisors" to help clients achieve and surpass their objectives. The Chicago office integrates seamlessly with Foley's national network, offering clients access to a vast pool of expertise across various practice areas, ensuring a comprehensive legal strategy. The firm's commitment to "exceptional client service, thought-leadership, value, and innovative strategy" is consistently recognized by clients and the legal industry.

Promotional information and accolades for Monica R. Chmielewski and Foley & Lardner LLP further highlight their strong reputation. Monica is a prolific author and speaker on health care and life sciences topics, regularly contributing to publications like "Health Care Law Today" and participating in significant industry events, such as the Clinical Trial Agreements Summit. Her recent co-authorship on topics like the vacating of FDA's Laboratory Developed Test (LDT) Final Rule and FDA & OHRP Draft Guidance on including tissue biopsies in clinical trials demonstrates her engagement with cutting-edge legal developments in the field. Her recognition as a vice chair of the firm's Health Care Practice Group and her contributions to publications like the "Clinical Research Compliance Manual: An Administrative Guide" underscore her leadership and expertise.

Foley & Lardner LLP as a whole receives consistent recognition in top legal directories. While general firm-wide environmental law accolades might be separate from Ms. Chmielewski's specific focus, the firm's overall robust performance in various practice areas, including its Health Care & Life Sciences sector, reinforces its credibility. For example, Foley & Lardner is often highlighted for its strength in areas relevant to the health care industry, such as corporate M&A, intellectual property, and general commercial litigation. The firm's commitment to thought leadership, as evidenced by its extensive publications and event participation, further promotes its expertise to the market. For any local user in Chicago, especially within the health care, pharmaceutical, or medical device sectors, seeking highly specialized and experienced legal counsel, Monica R. Chmielewski at Foley & Lardner LLP offers a distinguished and reliable choice within the "Nearby Lawyers" category.