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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