Achieve FDA Drug Compliance
with Confidence

Navigating FDA requirements for drug establishment registration and product listings can be complex and time-consuming. Owners and operators of U.S. and non-U.S. drug establishments involved in manufacturing, preparation, propagation, compounding, or processing of drugs must register and list every drug in U.S. commercial distribution—and renew these annually between October 1st and December 31st.

Let Registrar Corp simplify the process for you. With our expert team, we ensure your registrations and product listings are accurate, up-to-date, and compliant with FDA regulations. Save time, avoid costly mistakes, and focus on your business while we handle the complexities.

When registering with the FDA or filing a labeler code, companies must designate a registrant contact to handle submissions and communications with the FDA. For facilities outside the U.S., appointing a U.S. Agent with a physical presence in the country is also mandatory.

This is where Registrar Corp stands out. With years of expertise, a proven track record, and a dedicated team, Registrar Corp ensures seamless communication with the FDA and compliance with all requirements. Let us handle the complexities, so you can focus on growing your business with confidence.

The FDA provides monographs outlining specific requirements—like approved active ingredients, indications for use, dosage forms, labeling, and testing—that companies must meet to market an OTC product without going through the application review process.

Ensuring compliance with these strict standards can be complex, but that’s where Registrar Corp comes in. Our team simplifies the process by expertly verifying that your OTC product meets all FDA requirements before listing. Trust Registrar Corp to save you time, reduce risk, and ensure your product is ready for the market with confidence.

If your company needs to list drug products, obtaining an FDA labeler code is required. Don’t navigate the process alone—Registrar Corp makes it easy and stress-free. With our expertise and proven track record, we handle the labeler code assignment request efficiently, saving you time and ensuring compliance so you can focus on your business.

The FDA mandates that drug labels be indexed in Extensible Markup Language (XML) using the Structured Product Labeling (SPL) format—a process that can be complex and time-consuming. That’s where Registrar Corp comes in. Our team conducts a limited assessment of your drug labeling to identify any issues that could delay your drug listing.

To ensure full compliance, we offer our LabelComply service, which provides professionally revised graphic files ready for printing or editing, along with a detailed report outlining FDA regulations, compliance guides, warning letters, import alerts, and other critical guidance. Trust Registrar Corp to simplify compliance and help you avoid costly delays or penalties.

The FDA mandates that SPL files must be properly maintained and easily retrievable. Registrar Corp not only ensures your files are always up to date but also keeps them secure with our ISO 27001 certification—setting us apart as a trusted leader in compliance. With Registrar Corp, you can count on quick and hassle-free updates, giving you peace of mind and saving you valuable time. Trust the experts to simplify FDA compliance.

The CARES Act requires companies to report the amounts of their listed drug products to the FDA annually by March 31st. Meeting this requirement can be time-consuming and complex—but it doesn’t have to be. Registrar Corp simplifies the process with our easy-to-use reporting portal. Our software solution is designed to save you time, reduce errors, and ensure compliance.

Facilities producing or planning to produce generic drugs or APIs under an ANDA must submit “self-identification” information to the FDA annually between May 1 and June 1. Missing this deadline can result in costly delays or compliance issues.

Let Registrar Corp handle the process for you. With our expertise in FDA regulations, we ensure your information is submitted accurately and on time, helping you stay compliant and focused on your operations. Don’t risk unnecessary penalties—trust the experts at Registrar Corp.

The FDA charges annual fees for facilities producing generic drugs and over-the-counter monograph drug products. Missing the payment deadline doesn’t just mean extra fees—it could also land your facility on the publicly available “FDA Arrears List,” potentially harming your reputation and creating compliance headaches.

Registrar Corp simplifies the process, ensuring companies properly remit fees on time and stay in compliance. That’s where Registrar Corp comes in. With our expertise, we simplify the process, ensure timely payments, and help you stay compliant with FDA regulations. Don’t risk costly mistakes—let Registrar Corp handle it for you.

The FDA requires labels of OTC drugs marketed without an approved application to include a U.S. address or phone number to handle consumer reports of serious adverse events. Registrar Corp makes it easy to be compliant by serving as your U.S. Contact and ensuring timely and accurate forwarding of consumer reports to your business, helping you meet FDA requirements.

Registrar Corp’s innovative ComplyHub platform takes compliance to the next level. Powered by cutting-edge AI and historic supplier shipping data, it automates monitoring and document management—saving you time, reducing risk, and preventing costly supply chain disruptions. With Registrar Corp’s proven expertise in compliance solutions, you can trust ComplyHub to keep your operations running smoothly and effortlessly. Choose ComplyHub for a smarter, more reliable way to simplify compliance.

Border shipment delays can disrupt your business and increase costs, but Registrar Corp is here to help. With our swift, expert assistance, we resolve charges quickly and efficiently, ensuring minimal downtime. Our team handles submissions and communicates directly with compliance officers to streamline the process and get your shipments moving again. Trust Registrar Corp for fast, reliable solutions that keep your operations on track.

The FDA mandates that drug establishments have a unique identifier when registering and listing products, using Dun & Bradstreet’s Data Universal Numbering System (DUNS) for this purpose. Securing or updating a DUNS number can be a complex process, but that’s where Registrar Corp comes in. With our expertise, we simplify and expedite the process of requesting DUNS number assignments and making updates with Dun & Bradstreet. Trust Registrar Corp to handle the details, so you can focus on ensuring compliance and getting your products to market faster.

Companies exporting U.S. FDA-regulated products are frequently required by foreign customers or governments to provide an export certificate. This crucial document, issued by the U.S. FDA, verifies a product’s regulatory or marketing status—often a key step in gaining access to international markets.

Navigating this process can be overwhelming, but that’s where Registrar Corp comes in. With our expertise and deep understanding of FDA processes, we make obtaining an export certificate faster and easier, saving you time and ensuring compliance. Let us help you expand your business globally with confidence!

Import Alerts can cause major supply chain disruptions, putting your business at risk. Don’t let these setbacks slow you down. Registrar Corp specializes in creating comprehensive, evidence-based petitions to the FDA for removal, giving you the best chance at resolving the issue quickly and efficiently. Trust the experts to protect your operations and keep your supply chain moving.

Master Files are critical for protecting proprietary product data when submitting applications for drugs, biologics, medical devices, and veterinary products to regulatory agencies worldwide. They safeguard sensitive information about APIs, excipients, flavorings, packaging materials, and site data, ensuring confidentiality from applicant holders.

At Registrar Corp, we take the complexity out of the process. Our team expertly compiles and files submissions with regulatory agencies worldwide, all while maintaining top-tier security with our ISO 27001 certification. Choose Registrar Corp for trusted, secure, and seamless Master File management—because your data deserves the best protection.

Gain confidence in FDA compliance, GMPs, and drug safety protocols with our comprehensive online training. Designed for flexibility and convenience, our self-paced programs equip you with the knowledge and tools to excel at every stage of drug development, manufacturing, and market  approval — all on your own schedule. Crafted by industry experts with years of experience at Registrar Corp, these expert-led courses are tailored to fit seamlessly into your life, empowering you to achieve success with ease. View Catalog.