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news.The Food and Drug Administration (FDA) has allowed Laureate Biopharmaceutical's Regulatory Services Group (RSG) to submit the electronic common technical document (eCTD) regulatory submissions to the agency.
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The 4 gigabyte test submission comprising chemistry, manufacturing and control (CMC), preclinical and clinical data was reviewed, validated and approved without errors and in record time.
Regulatory Services vice president Robert Burford said clients will now be able to have their regulatory submission services provided by Laureate independent of having clinical supplies manufactured by them.
Laureate CEO Michael Griffith said 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.