I’m Gabriel Howard, an FDA regulatory specialist providing support for manufacturers, distributors, and businesses entering the U.S. market. I specialize in FDA medical device registration, 510(k) documentation, device listing, OTC drug registration, drug listing, MoCRA compliance, NDC guidance, SPL/XML support, label review, and US Agent services. I focus on accurate documentation, clear communication, and reliable regulatory support tailored to each client’s needs. My goal is to simplify FDA requirements and help clients prepare organized, clear documentation for their regulatory projects.... Lee más