Sonali Gunawardhana


Accomplished product legal responsibility, mass torts and white-collar partner April Byrd, has made a lateral move from Shook, Hardy & Bacon to Eckert Seamans in Philadelphia.

He often assists clients with GMP compliance, high quality system implementation, and FDA remediation. He additionally assists the tobacco industry in complying with the Deeming Rule necessities and ensuring compliance with the Family Smoking Prevention and Tobacco Control Act. Cirotta holds a Bachelor of Science diploma in chemistry from the University of North Carolina at Greensboro and an MBA from the University of North Carolina at Chapel Hill. Prior to attending regulation school, she worked within the non-profit sector the place she led group development initiatives designed to deal with numerous public well being issues in Houston, Texas together with working with well being care systems, affected person advocacy groups, and underserved communities to assist raise consciousness concerning the significance of breast most cancers screening and therapy. She additionally co-founded the former Houston-based non-profit breast well being screening and useful resource organization known as My Place, A Women’s Health Resource Center. Ms. Gunawardhana will counsel food and beverage, drug and device and dietary supplement companies on regulatory matters from Shook’s Washington workplace.

Ms. Gunawardhana joined Shook from Wiley Rein L.L.P., where she helped food and beverage companies as properly as pharmaceutical and medical gadget businesses in search of to resolve Food and Drug Administration challenges. The defense of FDA enforcement actions towards pharmaceutical, medical gadget, food, and dietary supplement corporations, Clinical Research Organizations , academic medical research institutions and particular person researchers. Works with food and pet meals companies and associations on issues corresponding to security, diet and well being, labeling, good manufacturing apply , packaging, biotechnology and the utilization of threat assessment and risk administration in regulation of the security of meals parts. Worked closely with medical device corporations and their counsel to deal with issues of noncompliance by submission of enough corrective motion plans.

Prior to being a companion at EAS, a firm that provides regulatory consulting to all of the FDA regulated industries, Cirotta was the President and COO of UPM Pharmaceuticals and the Vice President of Global Regulatory Affairs for Pharmaceuticals at Bausch & Lomb. He has 30 years of experience in the pharmaceutical, dietary supplement, and tobacco industries, together with government management roles with accountability for regulatory affairs, compliance, high quality assurance, laboratory operations, total corporate administration, and the last 10 years in consulting. In addition, Cirotta often speaks on FDA compliance and initiatives and is a lead coach for EAS.

From the University of New Hampshire School of Law; an M.P.H. from Boston University; an M.A. She is licensed to practice in the District of Columbia, Maryland, and New York. CARLA CARTWRIGHTis a member of the Johnson & Johnson Government Affairs & Policy (GA&P) coverage group where she manages quite a lot of global regulatory policy issues throughout the pharmaceutical, client and medical gadget sectors including importation, harmonization, and biosimilars. Regularly convening and leading cross practical group on key points, she works regularly with partners in legal, privateness, regulatory affairs, and provide chain. Cartwright leads on global policy issues related to digital and rising technology for GA&P and is the co-lead of the Digital and Emerging Technology Platform Team.

DANIEL KRACOVis a companion in Arnold & Porter Kaye Scholer’s Washington, DC office, the place he co-chairs the firm’s Life Sciences & Healthcare practice. He helps life sciences manufacturers, trade associations and early-stage ventures negotiate challenges relating to the development, manufacturing, approval and promotion of drugs michigan dispensary license cost, biologics, medical gadgets, and diagnostics. In addition to day-to-day regulatory counseling, he frequently handles excessive stakes investigations and enforcement proceedings, the event of world compliance applications, and due diligence in financings, mergers, and acquisitions.

She is recognized as a leading practitioner for all times sciences, food, and beverage legislation, and in the area of pharmaceutical and medical merchandise regulation. FREDERICK R. BALLis in the Boston workplace of Duane Morris LLP. Ball focuses his practice on helping companies or people when they are adverse to state or federal governments, including administrative, civil and legal issues, with the FDA, FTC, DEA, CMS, OIG and other federal and state regulatory agencies. He serves as a team lead for the Duane Morris Life Sciences/Biotech business group. He assists corporations bring product to market via patent evaluation, figuring out advertising and approval pathways, and, when essential litigation.

He is Vice-Chair of the Board for the Food and Drug Law Institute and is a graduate of Brandeis University and the Rutgers School of Law – Newark. CYNTHIA SCHNEDARis Executive Vice President of Regulatory Compliance at Greenleaf Health, the place she supplies strategic advice to purchasers within the life sciences business. She was formerly Director of the Office of Compliance for FDA’s Center for Drug Evaluation and Research , the place she spearheaded efforts to protect the American public from unsafe and ineffective drug merchandise by making certain that corporations comply with federal requirements for high quality and safety. Schnedar previously served on the Department of Justice as Acting Inspector General and in other management positions targeted on compliance and enforcement points.