FDA attorneys at the Law Offices of Alex R. Hernandez provide legal counsel to businesses that have to comply with FDA regulations. If you own a food, beverage, drug, or cosmetics business then you know that compliance with U.S Food and Drug Administration regulations is the difference between being able to do business and having to pay fines or even shut shop.  

If your company is planning to introduce new products then we can counsel you on the best approach for obtaining FDA approval and we’ll be by your side to resolve any complications that may come up during the review process.

Our attorneys can help you with the review of any claims that you intend to make with respect to dietary supplements and functional foods that you may market. These claims include health claims, nutrition value claims, and also guidelines on consumption for best results. We help our clients with food and beverage safety compliance issues, including product recalls.

Even if you are not directly required to fulfill FDA requirements, you may still be affected by FDA regulations. We counsel such businesses that include ingredient manufacturers for cosmetics, radiology centers, and biomedical research facilities.

Biotech and pharmaceutical companies have to ensure strict adherence to FDA regulations. We advise clients on clinical trials and regulatory compliance for both bulk and retail sales of prescription medicine and over the counter drugs.  

Our attorneys will ensure that you stay ahead of regulatory trends so that your business, both local and international, stays on track.

Compliance with FDA regulations requires constant monitoring throughout the product lifecycle, right from the pre-manufacturing stages.

We counsel clients who have received untitled and warning letters and, where required, represent them in court. Our FDA lawyers support clients executing corporate transactions and help in drafting IPOs as well as disclosures so that at any point in time the necessary safeguards with respect to FDA compliance are always in place.