Neelam Gill is an FDA and consumer products regulatory attorney who draws on her pharmaceutical experience in various quality and regulatory roles to provide practical guidance to industry on quality control, supply chain management, good manufacturing practices and labeling requirements.
Neelam’s practice focuses on the representation of clients in the e-cigarette and tobacco, cosmetic, pharmaceutical, medical device and food industries.
Drawing on her years of experience in the pharmaceutical industry, she regularly offers guidance to e-cigarette clients 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, Neelam routinely advises clients on other federal and state regulatory requirements, including those of the Consumer Product Safety Commission (CPSC), U.S. Department of Agriculture, Federal Trade Commission, Federal Communications Commission, Department of Homeland Security (DHS) and California Prop 65.
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. A key strength is her ability to think outside the box and come up with creative solutions when dealing with regulatory issues.
Representative Matters :
- Advises tobacco and e-vapor manufacturers, retailers and distributors on FDA product regulations and Deeming Rule compliance.
- Advised an e-cigarette company on PMTA requirements and FOIA disclosure considerations.
- Advises manufacturers on FDA inspection preparation and assists with responding to observations.
- Assisted a firefighter suit manufacturer with renewing its SAFETY Act designation and obtaining certification; assisted with quality requirements.
- Assisted a personal care and drug product manufacturer in overturning an FDA recall recommendation; advised on corrective and preventive actions for quality issues.
- Advises on current good manufacturing practice (cGMP) regulations and hazard analysis and critical control points (HACCP) issues in food manufacturing agreements.
- Advises consumer product manufacturers, suppliers and distributors regarding compliance with CPSC regulations. In particular, assists 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 :
- Member, Partners in Hope Program, St. Jude Children’s Research Hospital
- Board Member and Past President, Ohio Chapter, South Asian Bar Association of North America
- Member, Regulatory Affairs Professionals Society
- University of Akron School of Law, J.D., CALI Awards for International Law and International Trade, 2010
- John Carroll University, B.S., 2003
BAR ADMISSIONS : Ohio, U.S. Patent and Trademark Office
COURT ADMISSIONS : U.S. District Court for the District of Columbia
Rate : $$$$