Category: The FDA Advantage™
Founders spend years preparing for the perfect acquisition conversation. They perfect the brand. They build the customer base. They improve margins. They create a compelling growth story. Then the buyer asks for three years of quality records and everyone suddenly develops a new appreciation for spreadsheets. Regulatory readiness is often the difference between a smooth […]
Every marketing team wants the same thing: More views. More clicks. More shares. More sales. And sometimes, a little too much enthusiasm. A supplement that “supports wellness” suddenly “reverses disease.” A cosmetic that “improves the appearance of wrinkles” becomes a product that “rebuilds collagen and repairs damaged skin.” A beverage that “helps you stay hydrated” […]
Nobody wants to receive an unexpected message from FDA. Unlike your group chat, however, this is one message you do not want to answer with a quick reaction, a few promises, and a “we’ll get right on it.” When FDA issues a Form 483, Warning Letter, or identifies significant inspection observations, your next steps can […]
Your product made the journey across the ocean. It passed through manufacturing, packaging, shipping, customs paperwork, and weeks of logistics. Then it arrived in the United States and immediately hit a regulatory traffic jam. FDA detention notices can feel like a nightmare for food, beverage, dietary supplement, cosmetic, medical device, and OTC drug companies. Every […]
Congratulations. Your product is flying off shelves. Your social media team has mastered the algorithm. Investors are calling. The acquisition conversations have started. You are exactly where every founder dreams of being. And then diligence begins. Suddenly, the questions are not just about revenue growth, margins, and customer acquisition costs. A buyer’s legal team starts […]
★★★★★
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.
