Second Celsis Drug Master File Accepted by Food and Drug Administration.Accelerates Regulatory Approval Process to Use Celsis Rapid Detection System CHICAGO -- Celsis International plc, a Chicago-based life science products and services company, today announced that the US Food and Drug Administration (FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. ) has accepted a Celsis Drug Master File Drug Master File or DMF is a document prepared by a manufacturer in the pharmaceutical industry and submitted solely at his discretion to the Food and Drug Administration (FDA). There is no requirement by law or FDA regulation to present a DMF. (DMF (Distribution Media Format) A floppy disk format from Microsoft that was used to distribute its software. DMF floppies compressed more data (1.7MB) onto the 3.5" diskette, and the files could not be copied with normal DOS and Windows commands. A DMF utility had to be used. ) for Celsis AKuScreen[TM]. This is the second Celsis DMF that has been accepted by the FDA in the last four months. The Celsis DMFs provide specific technical and regulatory information to the FDA which allows companies wanting to use the Celsis Rapid Detection system to obtain regulatory approvals more efficiently. The Celsis Rapid Detection system was the first Rapid Microbiological Method (RMM RMM Mali (international vehicle registration) RMM Remote Management Module (SMC) RMM Relative Molecular Mass RMM Removable Media Manager RMM Read My Mind RMM Rio Music Manager ) to be approved in a regulatory filing for microbial microbial pertaining to or emanating from a microbe. microbial digestion the breakdown of organic material, especially feedstuffs, by microbial organisms. screening of pharmaceutical products in 1997. In addition, Celsis was the first provider to receive FDA acceptance of a DMF describing a RMM and is the only provider to have received FDA acceptance of two RMM DMFs. "Pharmaceutical and biopharmaceutical companies understand the benefits of faster product release with rapid microbial methods and are eager to implement rapid technology across a broad product range including raw materials, in-process and end products," said Diane Younker, Ph.D., Global Regulatory Affairs Regulatory Affairs (RA), also called Government Affairs, is a profession within regulated industries, such as pharmaceuticals, medical devices, energy, and banking. Regulatory Affairs professionals usually have responsibility for the following general areas: Many pharmaceutical companies have already submitted and received regulatory approval from the FDA, and other regulatory agencies, for using the Celsis Rapid Detection system. In fact, five of the top ten global pharmaceutical companies have received approval for its use in testing at least one of their products. With the FDA's acceptance of the Celsis DMFs, adoption of rapid methods by additional pharmaceutical companies will be more efficient. The Celsis Rapid Detection system provides significant economic value through a reduction in working capital requirements Capital requirements Financing required for the operation of a business, composed of long-term and working capital plus fixed assets. and manufacturing cycle times, improved cash flow and an ability to meet just-in-time demands. Furthermore, earlier identification of contamination events facilitates faster corrective action, minimizing the economic impact of these events when they occur. ABOUT THE CELSIS DMFs The Celsis DMFs share specific technical and regulatory information with the FDA, including details about reagent composition, claim support data and manufacturing details. The FDA will be able to evaluate pharmaceutical applications in conjunction with a Celsis DMF, when referenced by the customer. ABOUT CELSIS Celsis International plc Celsis International plc provides value enhancing products and services to the pharmaceutical, biopharmaceutical, and consumer products industries through its three business areas: rapid detection, analytical services and in vitro in vitro /in vi·tro/ (in ve´tro) [L.] within a glass; observable in a test tube; in an artificial environment. in vi·tro adj. In an artificial environment outside a living organism. technologies. The company is listed on the London Stock Exchange London Stock Exchange London marketplace for securities. It was formed in 1773 by a group of stockbrokers who had been doing business informally in local coffeehouses. (CEL CEL Cellular CEL Celestial CEL Check Engine Light CEL Degrees Celsius (temperature) CEL Comisión Ejecutiva Hidroeléctrica del Río Lempa (El Salvador) CEL Center for Entrepreneurial Leadership .L). Each division of Celsis has the capacity to deliver substantial time and cost savings to its customers, in addition to ensuring product quality and safety for consumers. Using proprietary technology, the rapid detection business is the world leader in the provision of diagnostic systems for the rapid detection of contamination. By reducing the time it takes to test and release raw materials and finished goods to the marketplace, Celsis technology facilitates increased manufacturing productivity and improved supply chain management. The analytical services division provides outsourced laboratory testing services to pharmaceutical and biopharmaceutical companies to ensure the stability and chemical composition of their products. In Vitro Technologies (IVT IVT intravenous transfusion. ) supplies in vitro testing products and services to the pharmaceutical and biotechnology industries. IVT's in vitro products and services screen drug compounds early in the discovery process, thereby reducing the time and cost of drug development. Further information can be found on its website at www.celsis.com. |
|
||||||||||||
Printer friendly
Cite/link
Email
Feedback
Reader Opinion