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DCL Extends Structured Product Labeling (SPL) Services to Meet New FDA Requirements;
Support Now Offered for CDER, CBER, CDRH, CVM and ONP Products
October 29, 2008 - Philadelphia, PA, and New York, NY- Data Conversion Laboratory, Inc. (DCL) (www.dclab.com), a leader in conversion services to pharmaceutical and health care organizations, announced the availability of enhanced Structured Product Labeling (SPL) services to meet the recently announced FDA requirements for SPL submissions of CDER (Human Prescription Drugs), CBER (Biologics), CDRH (Medical Devices), CVM (Veterinary Medicine), and ONP (Over-the-Counter) products.
While SPL has been required for CDER products for three years, the FDA is expanding the requirements to include Establishment Registration and NDC Labeler Code Requests. In addition, the FDA announced the requirement of SPL submissions for other FDA divisions (Animal and Veterinary Health, Biologics, Medical Devices and Over-the-Counter).
The extended services allow DCL customers to be fully compliant with FDA guidance without the need for extensive in-house expertise.
Howard Shatz, DCL's SPL Project Manager, notes that "Besides expanding the range of products requiring SPL, the FDA has also expanded the supporting information needed for a label submission. As we have done with SPL all along, we are making it as simple as possible for sponsors to have a fully compliant submission without the hassle."
"We are focused on providing customers with a complete solution that allows rapid compliance with FDA guidance without need for them to build an in-house staff. This expansion, beyond human prescription drug sponsors, reflects our commitment to provide customers more value in their regulatory efforts," said Mark Gross, DCL's President. "Customers love the ease and convenience of our SPL service, and we look forward to enhancing services and offering customers best-in-class SPL conversion efforts for these additional products."
About Data Conversion Laboratory, Inc.
Data Conversion Laboratory, Inc. is a leading provider of conversion services for mission critical applications. In health sciences DCL works with over 125 sponsors worldwide to facilitate compliance with the FDA's SPL initiative. Having completed over 2000 SPL conversions, DCL has worked with more sponsors for SPL conversions than all other vendors combined.