Neelam Gill

Associate

Washington, D.C.
Business Phone: 202.274.2909
Business Fax: 202.274.2994

Neelam.Gill@troutman.com

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Neelam is an FDA and consumer products regulatory attorney whose practice focuses on the representation of clients in the e-cigarette and tobacco, cosmetic, pharmaceutical, medical device, and food industries. She regularly offers guidance to e-cigarette clients drawing on her years of experience in the pharmaceutical industry on Deeming Rule compliance, as well as quality control and quality systems, supply chain management, good manufacturing practices, compliance policies, standard operating procedures, and labeling and promotional requirements. She also assists members of the food, cosmetic, medical device, and drug industries with regulatory compliance.

Additionally, she routinely advises clients on the requirements of other federal and state regulatory requirements, including those of the Consumer Product Safety Commission, U.S. Department of Agriculture, Federal Trade Commission, Federal Communications Commission, Department of Homeland Security, and California Prop 65 requirements.

Neelam also represents providers of anti-terrorism technologies in securing liability protections under the DHS Support Anti-Terrorism by Fostering Effective Technologies Act of 2002 (the SAFETY Act), including assistance with applications and SAFETY Act liability management.

Tobacco

  • Represents clients from the tobacco and electronic cigarette industries on various FDA regulatory issues, including marketing and labeling requirements, quality control manufacturing requirements, and new product filings.
  • Advise tobacco and e-vapor manufacturers, retailers, and distributors on FDA product regulations and Deeming Rule compliance.

Global Security

  • Represent providers of anti-terrorism technologies in securing liability protections under the DHS Support Anti-Terrorism by Fostering Effective Technologies Act of 2002 (the SAFETY Act), including assistance with applications and SAFETY Act liability management.

Cosmetics

  • Advises manufacturers of cosmetic and personal care products on product label reviews, including labeling claims and substantiation, FDA enforcement actions, warning letters, recalls, good manufacturing practices (“GMPs”), and importation and exportation.

Medical Devices

  • Advises clients on premarket issues and approval strategies, including clinical studies, marketing submissions, product classification, establishment registration and product listing, Quality System Regulation (“QSR)” requirements, medical device reporting, and EU Notified Body unannounced audits.

Food & Dietary Supplements

  • Advises marketers of conventional foods and dietary supplements in complying with FDA regulatory requirements, review labeling for issues such as health and “natural” claims, nutrient content claims, statements of nutritional support and other labeling for dietary supplements.
  • Also advise on cGMP and Hazard Analysis and Critical Control Points (“HACCP”) issues in food manufacturing agreements.

Drugs & Biologics

  • Advises on cGMP manufacturing requirements, due diligence assessment of investigational biologics, statutory and regulatory standards, approval strategies, clinical trial agreements, and post-approval support, including supplemental submissions and agency actions based on new information.

Consumer Products

  • Advises consumer product manufacturers, suppliers, and distributors regarding compliance with U.S. Consumer Product Safety Commission (“CPSC”) regulations. In particular, assist clients in understanding and adapting operations to comply with 2008 CPSC reform legislation and product certification and testing requirements, development of internal compliance programs, and risk management issues.

Professional and Community Involvement

  • St. Jude Children’s Research Hospital Partners in Hope Program
  • South Asian Bar Association of North America; Ohio chapter past president, board member
  • Regulatory Affairs Professionals Society

Rankings and Recognition

  • CALI Awards for International Law and International Trade
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Education

  • John Carroll University, B.S., 2003
  • University of Akron School of Law, J.D., 2010

Bar Admissions

  • Ohio
  • U.S. Patent and Trademark Office
  • District of Columbia

Court Admissions

  • U.S. District Court for the District of Columbia

Languages

  • Hindi
  • Punjabi