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 reg...