Achieve FDA Drug Compliance
with Confidence

Owners or operators of all U.S. and non-U.S. Drug Establishments that engage in the manufacture, preparation, propagation, compounding, or processing of drugs are required to register and submit a list of every drug in commercial distribution in the United States. Registration and listings are required to be renewed every year between October 1st and December 31st.

Companies who register establishments or file a labeler code with FDA are all required to designate a registrant contact who is responsible for submissions and communications from FDA. In addition to a registrant contact, for facilities located outside of the U.S. are also required a US Agent who resides and maintains a place of business in the US. Registrar Corp serves these roles.

FDA issues monographs that list certain requirements such as active ingredients, indication of use, dosage forms, labeling requirements and testing requirements to market an OTC without requiring an application review process. Registrar Corp verifies that these requirements are met prior to listing with FDA.

Companies required to list drug products are required to obtain a labeler code to list its drug products. Registrar Corp assists with requesting FDA labeler code assignments.

FDA requires that drug labels be indexed using Extensible Markup Language (XML) in Structured Product Labeling (SPL) format. Registrar Corp does a limited assessment of your drug labeling for issues preventing drug listing. To ensure label compliance, we will recommend LabelComply at an additional fee that provides revised graphic files ready to be printed or edited, and a report that details the regulations, compliance guides, warning letters, import alerts, and other guidance documents from FDA.

FDA requires SPL files to be maintained and retrievable. Registrar Corp assists with updating files and keeps these files secure with our ISO 27001 certification to ensure quick filing updates in the future.

Congress signed CARES Act that requires industry to file amounts of listed drug products to FDA each year by March 31st. Registrar Corp provides a portal for easy reporting. Easily report your amounts for each of your listed drug products with our software solution.

Operators of facilities that produce or intend to produce drugs marketed under an Abbreviated New Drug Application (ANDA) generic drugs and generic drug APIs must submit “self-identification” information to FDA between May 1st and June 1st of each year.

FDA charges annual government fees for facilities that produce generic drugs and over-the-counter monograph drug products. Registrar Corp helps companies understand the requirements and helps companies properly remit these fees to FDA.  Missing this deadline can subject companies to additional fees, as well as the facility being listed on a publicly available “FDA Arrears List” which can lead to further compliance issues.

FDA requires labels of OTC Drugs marketed without an approved application to bear a United States address or phone number to receive consumer reports of serious adverse events. Registrar Corp can serve as your U.S. Contact for the timely forwarding of consumer reports to your business as required by FDA.

Registrar Corp’s advanced ComplyHub platform leverages AI technology and historic supplier shipping data to automate monitoring and required document management. Avoid supply chain disruptions and keep your operations running smoothly with this powerful tool, designed to make compliance easier than ever.

Shipments stopped at the border create delays and drives up costs. Registrar Corp helps with resolving various charges with expedited response. We assist with submissions and communication with the compliance officer to help facilitate the situation.

FDA requires establishments to have a unique identifier when registering and listing drug products. FDA uses Dun & Bradstreet’s Data Universal Numbering System (DUNS) as the registration number for drug establishments. Registrar Corp assists with requesting DUNS number assignments and updating DUNS number records with Dun & Bradstreet.

Firms exporting products from the United States are often asked by foreign customers or foreign governments to supply an export certificate for products regulated by U.S. FDA. An export certificate is a document prepared by U.S. FDA containing information about a product’s regulatory or marketing status. Registrar Corp can help you obtain an export certificate.

Import Alerts can create serious supply chain disruptions if you don’t submit a request for removal. Registrar Corp can help you submit the most complete and evidence-based petition to FDA for removal.

Master Files are secure collections of proprietary product data sent to regulatory bodies around the world 
in support of drug, biologics, medical device, and veterinary product applications. This helps keep contract manufacturers of active pharmaceutical ingredients (APIs), excipients, flavorings, packaging materials 
and site data remain confidential from applicant holders. Registrar Corp assists with compiling 
submissions, filing with various regulatory agencies around the world, and keeps those submissions 
secure for our clients.

Gain critical knowledge in FDA compliance, GMPs, and drug safety protocols. Our comprehensive training prepares you for every step of drug development, manufacturing, and market approval. Registrar Corp 
has spent the last two decades helping over 30,000 companies each year across 180+ countries 
successfully navigate the complexities of compliance regulations. We can help you, too, with self-paced training experience. View Catalog.