We serve U.S. and international clients with compliance matters.
We are a regulatory partner for product compliance to legally launch an FDA-regulated product in the U.S., to avoid FDA enforcement action, and to work with you through any bumps along the way.
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.
Representative experience
- 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
Specific representations
Importation, exportation, and regulation of foods, dietary supplements, beverages, cosmetics and personal care products, over-the-counter drugs, and medical devices.
★★★★★
Working with Shelly on various new product launches over the last couple of years has been seamless. Quick and clear guidance is always what we get.
I've been working with Shelly and her team at Garg law for a little while now and they are fantastic! Very responsive, professional and they certainly get things done. Extremely satisfied with their service and highly recommend.
Ms Garg helped my company navigate an FDA import issue. She achieved an excellent result, was very responsive and professional, and managed to keep the project within budget. She is a stellar attorney.
I have been using Shelly Garg as FDA Counsel for 10+ years, since she was at another international law firm. While we continued to use the previous firm she was at (mainly due to the process required to change firms), we realized the quality of counsel was not the same. We have since been using Garg Law and the ease of use and trust in the knowledge was back instantly. Shelly has the skills to help me understand the regulations (by translating into layman's terms) and risks in a manner that is specific to my business. She is also extremely timely in her responses which is critical when we have a deadline mandated by the FDA. Many other attorneys cite the regulations which l've already read, but need further counsel. In my opinion, this demonstrates Shelly's in-depth knowledge of the regulations, how they pertain to the law, and how they are applicable IRL. Shelly's personable approach and pleasant manner in communication makes it very easy to have been work with her and have productive discussions on the best next steps. She truly has a passion iternational for all things FDA and I've learned so much from her.