We serve U.S. and international clients with compliance matters.
Above and beyond
Our practice is focused in the following areas:
Regulatory compliance including FDA, CBP, and USDA regulation of foods, beverages, dietary supplements, cosmetics, Over-the-Counter drugs and medical devices.
With background in national firms and boutique practices, Shelly Garg founded this minority-owned and operated law firm to offer clients the experience, skill, and training associated with larger law firms while offering more personalized attention in a cost-efficient structure.
No matter the issue confronting our clients, our focus is to solve their problems with business and legal considerations in mind, and to achieve the best possible result for the client with professionalism, value, and a dedication to excellence.
While the core area of our practice is FDA regulatory compliance, we assist where there is overlapping jurisdiction by other federal agencies including USDA, EPA and TTB.
- Successfully removed food company from Import Alert after decades-long placement, permitting US market access
- Negotiated release of various FDA-regulated products following FDA detention
- Mitigated liquidated damages claim for confectionary business by 1%
- Successfully limited recall scope for cosmetics manufacturer and provided strategic guidance during recall
- Provided strategic counsel on formulation of OTC Drug in compliance with Monograph requirements
- Developed regulatory rationale for positioning of general wellness device
- Provided strategic counsel on regulatory classification of medical device
- Advised on product labeling and packaging requirements
- Advised on EPA pesticide tolerances for food products
- Obtained USDA VS Permits for animal-origin containing materials of FDA-regulated products
- Obtained TTB beverage alcohol permits for wholesaler