The U.S. Food and Drug Administration (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.
U.S. FDA Drug Establishment Registration and Listings
U.S. FDA Drug Establishment Registration and Listing Verification
Between October and December of 2017, drug establishments were required to renew their FDA registration and submit a “blanket no-change” certification for all drug listings that received no changes within the year. Registrar Corp can verify whether your drug establishment registration and listings are valid at no cost.
Drug Labeling and Ingredient Reviews
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 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 FDA.
U.S. FDA Drug Master Files (DMF)
A Drug Master File is a submission to 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.
U.S. FDA Adverse Event Contact for OTC Drugs
U.S. 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.
U.S. FDA Outsourcing Facility Regulations
Compounding Pharmacies that register with FDA as Outsourcing Facilities may qualify for exemption from certain FDA approval and labeling requirements. Registrar Corp’s Regulatory Specialists can register pharmacies as Outsourcing Facilities as well as help them comply with FDA’s regulations for doing so, including submission of annual drug product reports.
U.S. FDA Self-Identification Requirements for Generic Drug Facilities
Data Universal Numbering System (D-U-N-S®)
U.S. FDA 3PL/WDD Reporting
U.S. FDA Drug Color Additives and Drug Color Batch Certification
Certificate of U.S. FDA 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 FDA. Products subject to DWPE are held at the port of entry while FDA performs additional scrutiny, testing, and analysis. Delays from DWPE may be lengthy for businesses anxious to deliver products on schedule.