Neelam Gill advises clients in the areas of food and drug law and tobacco and e-vapor law, counseling both domestic and international corporations on product and regulatory compliance issues involving the U.S. Food and Drug Administration (FDA).
In her tobacco and e-vapor practice, Neelam advises tobacco, e-cigarette, and e-liquid manufacturers, distributors, retailers, suppliers, and trade associations on FDA, state, and global regulatory compliance issues. In the food and drug arena, she assists clients with a variety of FDA regulatory matters and labeling issues. Neelam’s background and experience in the pharmaceutical industry serves her well in advising clients on the complexities of the Family Smoking Prevention and Tobacco Control Act. Neelam’s background gives her unique expertise with quality systems and good manufacturing practices (GMP), which positioned her to spearhead the practice’s Quality and Tobacco Product Manufacturing Practices (TPMP) and GMP section.
Neelam advises clients on preparation of FDA submissions, including premarket tobacco product applications (PMTAs), substantial equivalence (SE) reports, tobacco product master files (TPMFs), and quality issues pertaining to the entire tobacco and nicotine product lifecycle. She helps guide manufacturers of novel nicotine-containing products, e-cigarettes, hookah/waterpipe tobacco, and conventional tobacco products (e.g., cigarettes, smokeless tobacco, cigars, pipe tobacco, etc.). Neelam also assists clients with communications with FDA’s Center for Tobacco Products and advises on federal and state advertising and promotion restrictions and warning labels applicable to tobacco products, such as California Proposition 65. Neelam further assists tobacco and e-vapor clients with scientific literature review, stability and other testing requirements, marketing plans, post-market surveillance, client testimonials and social media considerations, age verification (online and in-person), and environmental assessments. She is regularly invited to train clients on preparing for FDA inspections and remote regulatory assessments. Additionally, she routinely advises clients on highly technical issues pertaining to tobacco and nicotine product research and regulatory requirements to support marketing applications.
Prior to joining Keller and Heckman, Neelam practiced FDA, life sciences, and consumer products regulatory law. She also has extensive experience in the pharmaceutical industry, where her work involved quality systems, current good manufacturing practices (cGMPs), Standard Operating Procedures (SOPs), product filings, regulatory inspections, product certification and testing, internal compliance programs, risk management, supply chain management, and other areas of FDA compliance. Neelam draws upon her industry knowledge and experience to assist clients with compliance and business concerns specific to FDA-regulated industry.
- Provided regulatory counsel and support regarding Tobacco Control Act requirements for vaping industry clients
- Assisted vaping industry clients with FDA inspections
- Advised e-cigarette company on FDA recall procedures and helped to overturn recall recommendation
- Prepared PMTA submissions for tobacco and e-vapor clients
- Assisted international clients with TPMF submissions and requirements
- Provided assistance to national tobacco and e-vapor associations with submitting comments and the development of FDA rulemaking
- Developed quality system and compliance programs for national vaping clients