09.09.11
Laureate Biopharmaceutical Services’ Regulatory Services Group (RSG) has been approved by the FDA to submit electronic common technical document (eCTD) regulatory submissions. The four-gigabyte test submission comprising CMC, preclinical and clinical data was reviewed, validated and approved without errors.
“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,” said Robert Burford Ph.D. 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.”
“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,” said Robert Burford Ph.D. 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.”