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Reed Tech SingleSource for Drug Products – New Enhancements

Drug & Biologic Product Submissions, Pharmaceutical and Cosmetics

SingleSource™ for Drug Products helps regulatory professionals manage drug product meta-data with an intuitive...

The Anatomy of a National Drug Code (NDC)

Drug & Biologic Product Submissions, Pharmaceutical and Cosmetics

The National Drug Code (NDC) is a unique 10-digit number assigned by the FDA to identify drug products in the U.S., consisting of a labeler code, product code, and package code segments. The NDC Directory contains data on prescription drugs, over-the-counter medications, and insulin products available in the market.

Electronic Drug Listing and Registration Guides

Drug & Biologic Product Submissions, Pharmaceutical and Cosmetics

To learn the main requirements for Electronic Drug Registration and Labeling (eDRL), download a quick-reference guide...

UDI Labeling (Unique Device Identification): Best Practices

Medical Devices, Unique Device Identification

Unique Device Identification (UDI) labeling remains a hot topic among medical device manufacturers under pressure to comply with UDI requirements for US FDA GUDID and other emerging health authorities around the globe. EU EUDAMED is underway and China’s NMPA, South Korea and others have published guidelines. UDI is becoming integrated into medical device labeling all over the world. Medical Device manufacturers doing business globally will encounter growing regulatory complexity, while also ensuring quality, streamlined processes and cost control.