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Laureate's Electronic Submission Gateway Approved

Fri, 06/24/2011 - 6:35am
Bio-Medicine.Org

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." <

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