FRESH MEADOWS, N.Y., Aug. 4 /PRNewswire/ -- Data Conversion Laboratory, Inc. (DCL), providing conversion services and software to publishers, information aggregators, industry, government, libraries and documentation developers, continues to be in the forefront supporting the life sciences community in complying with the FDA's SPL (Structured Product Labeling) initiative.
SPL is an XML standard used by the FDA community to facilitate communicating drug labeling data reliably among various medical groups. Since 2005, the FDA CDER division has mandated that all human prescription drugs be provided in SPL. Beginning in June, 2009 the FDA has required SPL filings for biologics, veterinary medicines and over-the-counter (OTC) products. Medical devices are expected to require SPL filing in 2010. Additionally, as a result of the Food and Drug Administration Amendments Act of 2007 mandating electronic submissions, SPL is now required for establishment registration, NDC labeler code requests and drug listing regulatory requirements.
As one of the world's leading providers of data conversion services, DCL has been well-positioned to understand the structure and usage of this new standard, and to assist affected organizations in implementing and utilizing SPL in a timely and efficient manner. DCL supports the full range of SPL filings, is up to date on all technical requirements and has implemented sophisticated multi-level quality assurance checks to validate SPL files prior to submission. To date, DCL has successfully completed more than 2,000 filings.
Mark Gross, DCL president, expanded on DCL's involvement with these regulations: "As a long-time member of the SPL Working Group helping to establish these standards, we were very comfortable with SPL from the beginning. As standards continue to evolve, our 28 years of industry experience and our ongoing interaction with the group enable us to provide rapid turnaround in support of our clients' labeling conversions with guaranteed conformance to FDA and EMEA standards."
About Data Conversion Laboratory, Inc.
Founded in 1981, DCL converts and organizes content to create electronic documents, populate databases and publish on the web, sustaining long-term strategic relationships with clients preparing for tomorrow's technology. DCL operates with facilities on four continents, providing support services for high-volume data-entry and data-processing using its real-time web-accessible process control software. DCL's services help refine conversion strategy, identify document redundancy, extract metadata and transform legacy and future documents to meet our clients' real needs - today and in the future. DCL converts from any format to any format, and has processed more than a quarter billion pages.
Contact: Don Bridges, SPL Product Manager 505-275-2223 firstname.lastname@example.org www.dclab.com
|SOURCE Data Conversion Laboratory, Inc.|
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