Top best Health Care Lawyers Near me in ZIP 20001

I joined Keller and Heckman in 2010 as a member of the firm’s Food and Drug Practice. I assist companies, organizations and trade associations in establishing compliance with regulatory requirements for food packaging and food ingredients throughout the United States, European Union (EU), Asia and South America (including the Common Market of the South, MERCOSUR). Leveraging my background and experience as an Industrial Engineer, I appreciate both the technical and legal aspects of the unique challenges faced by industry in navigating the complex regulatory systems in place across the world. In this regard, I have assisted clients in establishing a suitable U.S. Food and Drug Administration (FDA) status, and exemption from premarket review, for a variety of food-contact materials, and have successfully filed numerous Food Contact Notifications (FCNs) with FDA for new and innovative polymers, additives, and processing aids used in the manufacture of food-contact articles. In addition, I assist clients in evaluating the suitable status of food-contact materials under the EU Framework Regulation, and the Plastics Regulation (EU) No. 10/2011. As a former supply chain analyst for a Pittsburgh, Pennsylvania-based medical device manufacturer, I have experience in process optimization, inventory control, facility layout and good manufacturing practice (GMP) in FDA-regulated facilities. I use this experience to assist clients in developing strategies to prevent and, when necessary, respond to contamination and “accidental additive” situations that arise during the manufacturing and transportation of food-contact materials.

I help healthcare providers to navigate the U.S. healthcare system, the most highly regulated industry in the United States. My practice assists small to mid-sized medical practices, mental healthcare providers, dental clinics, medical spas, and durable medical equipment providers with growing their business by maximizing earnings and overcoming regulatory hurdles. I have a proven record of successfully disputing denied medical claims, removing providers from prepayment reviews and post-payment audits, assisting healthcare practices with regulatory compliance matters, and defending providers against allegations of fraud and abuse.. I also work with clients outside of the healthcare realm, providing counsel regarding administrative, contractual, trademark, and civil litigation matters.