CGMP Radiolabeling & Synthesis Subhead Needed Few contract research laboratories maintain the rigorous CGMP-compliant environment required to produce certified radiolabeled product suitable for human clinical trials. ABC Laboratories maintains four Class 10,000 CGMP Synthesis suites, a dedicated Quality Assurance staff and a group of analytical chemists with years of experience supporting labeled isotope studies. This unique capability complements in-house drug metabolism and impurity ID expertise and streamlines project management. Clinical Support GMP API suitable for early clinical trials, including Phase 0 microdosing studies Radiolabeled (14C) GMP API for early clinical trials Radiolabeled (14C) GMP drug product formulations Analytical support dedicated to synthesis activities Method development and early phase validation Certificate of analysis generation ABC possesses deep experience with all types of chemistries: Lithiation, Grignard, epoxidation, nitration, metal catalysis--as well as chiral separation and asymmetric synthesis...and all types of compounds, including carbohydrates, polymers, amino acids, peptides, nucleosides, nucleotides, and steroids. ABC Laboratories has four Class 10,000 synthesis suites for producing radiolabeled CGMP product, and a dedicated analytical team to deliver batch records and Certificates of Analysis.