Laureate Biopharmaceutical Services, Inc. announced 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 FDAs 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 PhD, 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.”
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.
Laureate Biopharmaceutical Services, Inc. is a full-service biopharmaceutical contract development and manufacturing organization.
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