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FDA Approves Electronic Common Technical Document (eCTD) for Laureate Biopharmaceutical Services, Inc.'s Regulatory Submissions


9/8/2011 11:39:51 AM

PRINCETON, N.J., Sept. 8, 2011 /PRNewswire/ --Laureate Biopharmaceutical Services, Inc. announced today that their Regulatory Services Group (RSG) has been approved by the Food and Drug Administration (FDA) to submit electronic common technical document (eCTD) regulatory submissions to the Agency. The 4 gigabyte test submission comprising CMC, preclinical and clinical data was reviewed, validated and approved without errors and in record time. The endorsement complements Laureate's recent approval to use FDA's electronic submission gateway (ESG).

"This is a major milestone towards completing Laureate's strategy of offering clients submission-ready chemistry, manufacturing and control (CMC) reports, as well as providing a complete regulatory submission service," commented Robert Burford Ph.D. Vice President Regulatory Services. "Clients will now be able to have their regulatory submission services provided by Laureate independent of having clinical supplies manufactured by us."

Laureate's CEO, Michael A. Griffith, commented, "Approval to submit eCTDs to the FDA along with the recently announced approval to use FDA's electronic submission gateway offers Laureate customers a combined service, unique to the industry." He continued, "By providing clients with a bulk drug substance (BDS) and/or drug product along with submission-ready CMC documentation and the capability to manage the actual submission process is part of Laureate's philosophy of providing clients with a superior contract manufacturing experience."

About Laureate Regulatory Services Group (RSG)

Laureate Regulatory Services Group publishes, submits and manages electronic IND, NDA and BLA submissions as a client service. Specializing in CMC documentation from Upstream, Downstream and Analytical functions performed for clients requiring BDS these reports are created in eCTD format. Besides publishing and submission services, the RSG also offers a wide range of regulatory support activities including high level consulting re: regulatory strategy, IND completion, report generation and regulatory submission reviews. For more information, contact: Robert Burford, Ph.D., VP Regulatory Services Group, Laureate Biopharmaceutical Services Inc., at (609) 919-3332, or email Robert.Burford@LBioS.com, or visit www.LBioS.com.

About Laureate Biopharmaceutical Services, Inc.

Laureate Biopharmaceutical Services, Inc. is a full-service biopharmaceutical contract development and manufacturing organization. Laureate Biopharma's scientists are expert in process development and cGMP production of therapeutic proteins including monoclonal antibodies and Fc-fusion proteins. In addition, the company's portfolio of services includes aseptic filling, cell line development, analytical and stability testing, and regulatory support. Laureate Biopharma has served a global client base from its Princeton, New Jersey facility since 1981 and is a portfolio company of Saints Capital, LLC. For more information, please visit www.LBioS.com.

About Saints Capital, LLC

Saints Capital is a leading direct secondary acquirer of venture capital and private equity investments in emerging growth companies around the globe. It also makes traditional direct venture capital investments on a primary basis and in special situations in technology, healthcare, consumer and industrial companies in the United States. Founded in 2000, Saints provides liquidity for private investors in such markets as investment and commercial banks, buyouts, corporate venture capital and hedge funds. Saints has more than $1 billion of committed capital under management, over 50 completed portfolio transactions and investments in more than 200 companies. For more information, please visit www.saintsvc.com.

For more information, contact: Imara Charles, Ph.D., Director of Project Management, Laureate Biopharma, at (609) 919-3367, or info@LBioS.com or visit www.LBioS.com.


SOURCE Laureate Biopharmaceutical Services, Inc.


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