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INSIGHTS

Behind the Scenes with ORA

Featuring news, conversations, media coverage and “behind the scenes” stories, this month’s feature article, …

In September, FDA’s Office of Regulatory Affairs (ORA) officially launched ORA News and Stories, a brand new, public-facing platform on FDA.gov, which provides unique stories of what ORA does at the forefront of public health. Featuring news, conversations, media coverage and “behind the scenes” stories, this month’s feature article, Scrutiny and Safety at Toyosu Market, takes consumers along Consumer Safety Officer Derek Dealy’s investigation of one of the largest wholesale fish markets in the world. With more than 90 percent of U.S. seafood coming from other countries, and concerns over vulnerabilities during transportation, including proper refrigeration, and bacterial growth, the investigator discusses particular focus on evaluating scombrotoxin risk.

Microbiologist Nancy Miranda’s work is highlighted in another feature, where she discusses how her team and lab colleagues are tracking down pathogens, such as Cronobacter sakazakii, in infant formulas.

Do we see a new reality TV show in the making? Maybe not yet, but the new site certainly provides some refreshing perspective of ORA’s work and gives regulated industry an additional opportunity to learn about ongoing FDA enforcement priorities.

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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.
R.G. Client
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.
Mike H. Client
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.
Dr. Sastry Client
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.
Claire P. Client

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