Horsham, PA (PRWEB) April 17, 2015
Reed Technology and Information Services Inc. (Reed Tech), a leader in regulatory data management, preparation, and submission to the U.S. Food and Drug Administration (FDA), announced today the availability of a new Lot Distribution Report (LDR) service for manufacturers of biologics, including vaccines, that are required to remain compliant with the FDA’s new rule on electronic submission of LDRs.
Used by the FDA to monitor the volume and timing of particular biologics introduced to the marketplace, LDRs are currently submitted as PDF versions of spreadsheet data by manufacturers holding a Biologics License Application (BLA) to the Center for Biologics Evaluation and Research (CBER) or the Center for Drug Evaluation and Research (CDER). Per FDA guidance, beginning June 10, 2015, manufacturers of biologic products must submit LDRs to the FDA in an electronic HL7 Structured Product Labeling (SPL) XML format that the agency can process, review, and archive in order to ensure a greater degree of accuracy and reduce reporting errors. The new rule requires biologics manufacturers to submit the specified LDRs every six months, unless a more detailed report or a different schedule is requested by the FDA.
Biologics manufacturers can leverage the deep SPL experience of Reed Tech and its superb customer satisfaction record to remain compliant with these new LDR submission requirements in a cost-effective manner. Complementary to manufacturers’ current internal processes, the Reed Tech LDR solution accepts data from existing systems, which can easily be captured through the use of a Reed Tech data template that contains all the newly defined LDR data fields. The Reed Tech LDR system validates the dataset to current FDA specifications and builds LDRs in the compliant SPL format. Reed Tech will then return the SPL to the manufacturer for inclusion in a BLA supplement.
“We are very pleased to assist biologics manufacturers in successfully meeting these new regulatory challenges,” said Ben McGinty, Senior Director, Business Development – Life Sciences at Reed Tech. “Reed Tech is uniquely positioned to provide this LDR service as a leader in SPL content transformation for the pharmaceutical industry and as a participant in the two CBER pilot programs for LDR submissions. The Reed Tech Life Sciences team gained invaluable insights from the pilot programs, building on our decade of experience in submitting SPL XML data to the FDA. We look forward to applying our expertise to support our biologics customers.”
Biologics manufacturers that would like more information on new FDR mandates can download a free Reed Tech LDR Readiness Kit at http://go.reedtech.com/download-free-ebook-ldr-readiness-kit-0
About Reed Tech:
Reed Tech is the provider of best-in-class information-based solutions and services to meet the broad needs of the global Intellectual Property market as well as key regulatory needs of the Life Sciences industry. Our customers include the U.S. Patent and Trademark Office, IP-driven companies, law firms, and a wide range of pharmaceutical and medical device manufacturers. The corporate culture is driven by a commitment to excellence, innovation, and a strong dedication to its customers, employees and community. Reed Tech has worked in the patent arena since 1970 and has electronically captured and prepared for publication well over half of all U.S. patents ever granted by the U.S. Patent and Trademark Office (USPTO). Reed Tech is a LexisNexis company.
About LexisNexis Legal & Professional:
LexisNexis Legal & Professional is a leading global provider of content and technology solutions that enable professionals in legal, corporate, tax, government, academic and non-profit organizations to make informed decisions and achieve better business outcomes. As a digital pioneer, the company was the first to bring legal and business information online with its Lexis® and Nexis® services. Today, LexisNexis Legal & Professional harnesses leading-edge technology and world-class content to help professionals work in faster, easier and more effective ways. Through close collaboration with its customers, the company ensures organizations can leverage its solutions to reduce risk, improve productivity, increase profitability and grow their business. LexisNexis Legal & Professional, which serves customers in more than 175 countries with 10,000 employees worldwide, is part of RELX Group plc, a world-leading provider of information solutions for professional customers across industries.
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