The U.S. FDA regulates drug products intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease and intended to affect the structure or any function of the body of humans or animals. Registrar Corp provides Registration, U.S. Agent, and Compliance Assistance for U.S. and Non-U.S. Companies in the Drug Industry.
Drug Establishment Registration and Listings
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 by way of U.S. FDA’s Electronic Drug Registration and Listing System (eDRLS).
Drug Labeling and Ingredient Reviews
The U.S. FDA requires that drug labels be indexed using Extensible Markup Language (XML) in Structured Product Labeling (SPL) format. Registrar Corp can help modify your drug labeling to comply with U.S. FDA regulations. Registrar Corp 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 the U.S. FDA.
FDA Drug Master Files (DMF)
A Drug Master File is a submission to the U.S. FDA that may be used in support of pre-market submissions to provide confidential, detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of one or more drugs. Registrar Corp’s team of Regulatory Specialists provide guidance as to required elements, formats, and particularities of Drug Master File submissions.
Certificate of Registration issued by Registrar Corp
Detention Without Physical Examination ("DWPE") Assistance
Companies shipping products to the United States may find their shipments subject to Detention Without Physical Examination (“DWPE”) by U.S. FDA. Products subject to DWPE are held at the port of entry while U.S. FDA performs additional scrutiny, testing, and analysis. Delays from DWPE may be lengthy for businesses anxious to deliver products on schedule.