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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.
New Drug Establishment Registration & 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 new Electronic Drug Registration and Listing System (eDRLS).
Data Universal Numbering System (DUNS Number)
FDA requires Data Universal Numbering System (DUNS) numbers for drug establishments as well as the registrant owner of the establishment if it is in a different location.
Drug Labeling and Ingredient Reviews
The U.S. FDA now 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.
New FDA Self-Identification Requirements
Operators of facilities that produce generic drugs and generic drug APIs are required to submit "self-identification" information to the U.S. FDA by December 3, 2012. The law imposes a new user fee on certain companies identified in generic drug submissions, including Abbreviated New Drug Applications (ANDA), amendments to ANDAs, and Prior Approval Supplements (PAS). Not all establishments will be required to pay the fee. Operators of generic drug facilities and certain sites and organizations that are identified in a generic drug submission must submit self-identification information to FDA, from which FDA will determine which firms must pay the new user fees and in what amount. The fee schedule is expected to be published by FDA by January 31, 2013.
Drug Color Additives and Drug Color Batch Certification
A drug color additive is any dye, pigment, or other substance that can impart color to a drug product. Drug color additives are regulated by the U.S. FDA.
U.S. FDA Drug Master File (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
Companies registered with U.S. FDA often are asked by their customers and suppliers to verify their U.S. FDA registrations. A Certificate of Registration issued by Registrar Corp serves as a third-party verification of your U.S. FDA registration.
Detention Without Physical Examination ("DWPE") Assistance
Companies shipping products to the United States may find their shipments subject to "Detention Without Physical Examination" by U.S. FDA. Products subject to detention without physical examination are held at the port of entry while U.S. FDA performs additional scrutiny, testing, and analysis. Delays from detention without physical examinationf may be lengthy for businesses anxious to deliver products on schedule. For assistance with a detention, simply click on the Notice of Action shown on the left.
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