Manufacturers
Business clients
Ensure compliance with current GMPs
Manufacturers (food and dietary supplement manufacturers, cosmetic manufacturers, manufacturers of housewares and food related products, medical device manufacturers, and manufacturers of drugs and biologics) look to the U.S. market for opportunities to significantly expand their business. With our legal expertise and regulatory compliance services, foreign and domestic manufacturers have support in ensuring regulatory compliance, responding to regulatory enforcement issues and finding new buyers and partners.
Whether you are a foreign or domestic manufacturer seeking to market FDA-regulated products in the U.S., you must ensure that products are compliant with U.S. laws and regulations. Manufacturers of foods, dietary supplements, cosmetics and personal care products, medical devices, Over-the-Counter (OTC) drugs, animal and veterinary products, beverage alcohol, and the products themselves, are subject to inspection when offered for import into the U.S., and/or via routine or surveillance inspections (domestic or foreign). Accordingly, manufacturers must ensure compliance with current Good Manufacturing Practices (GMPs) or Quality Systems, applicable registration and product listing, permits, labeling, recordkeeping, reporting and more. For foods, this may also mean compliance with FDA’s Food Safety Modernization Act (FSMA) including Food Safety and Preventative Controls plans. Manufacturers are also advised to have manufacturing and quality agreements in place with buyers to properly identify and allocate regulatory liability.
Compliance with U.S. requirements for manufacturing helps reduce FDA enforcement costs including costs associated with inspections, product delays, and placement on Import Alert. Compliance also supports consumer confidence, positive trade flow and profitability.
★★★★★
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.