PRINCETON, N.J., June 24, 2011 /PRNewswire/ -- Laureate Biopharmaceutical Services, Inc. announced today that the U.S. Food and Drug Administration (“FDA”) approved its application for an Electronic Submissions Gateway (ESG) to the Agency. The gateway will allow Laureate to offer clients a validated, direct electronic path for IND (Investigational New Drug), NDA (New Drug Application) and BLA (Biologic License Application) submissions and builds upon a previous commitment to provide submission-ready CMC (Chemistry, Manufacturing and Control) documentation for client biological drug substance projects. Creation of this electronic, new product filing path, was spearheaded by the Regulatory Services Group, who have extensive experience generating eCTD documents and publishing regulatory submission in XML format.
Commenting on this development Laureate’s CEO, Michael A. Griffith, said, “We believe the future of new drug development will rely on adoption of better, more cost-effective ways of doing business and the ESG is a perfect example.” Continuing on he said, “Being able to eliminate paper reports, batch records and submissions just makes sense and apparently the FDA agrees. Now, we will be able to provide clients with submission-ready CMC documentation AND offer a path for submission to the FDA. If that is not a first in the industry it certainly underscores our commitment to provide each client with the best possible value for their CMC dollar.”
Robert Burford, Ph.D., Vice President Regulatory Services said, “Besides publishing and submission services, Laureate will offer a wide range of regulatory support activities to its clients including high level consulting services for regulatory strategy, IND completion, report generation and regulatory submission reviews.” Continuing he said, “When a client chooses Laureate as its contract manufacturing organization, it gets a committed partner capable and ready to see a project through to submission.”
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: Robert Burford, Ph.D., Vice President, Regulatory Services Group, Laureate Biopharmaceutical Services Inc., at (609) 919-3332, or email Robert.Burford@LbioS.com, or visit www.LBioS.com.
SOURCE Laureate Biopharmaceutical Services, Inc.
