Radiolabeling w/ GLP Certification Talent. Experience. Agility. And a steadfast dedication to being on time. Expert 14C radiolabeling for human clinical programs requires extensive training and experience. Having supported radiolabeled studies for more than 10 years, ABC Laboratories was one of the first to synthesize 14C-labeled API and formulate to prepare drug product under CGMP. Our experienced radiosynthethic chemists have worked with many drug candidates so we can help guide you through the detailed CGMP process. We work in tandem with your chemistry, regulatory, and QA personnel to ensure that a high-quality API or drug product, that meets your specifications, is delivered to the clinic on time. We know you're counting on us ABC's experienced scientists have worked on both sides of the outsourcing relationship, so we understand the criticality of meeting timelines with high-quality deliverables. ABC maintains a dedicated Quality Assurance staff and a group of QC analytical chemists with extensive experience specifically supporting isotopically labeled compounds. Nowhere will you find a team with more skill in developing efficient synthetic routes, or more commitment to delivering quality labeled drug candidate, batch records and Certificates of Analysis in the agreed-upon time. The broad capabilities of ABC's Synthesis Services complements in-house drug metabolism, impurity ID and environmental assesment expertise. We also offer Program Management services to help streamline communication through your CGMP project or through the lifetime of your multi-faceted program. We support the full range of DMPK, bioanalytical and analytical studies with CGMP as well as research-grade and GLP certified materials--including APIs, reference materials, intermediates, and other standards used for impurity and metabolite identification. Let us show you how to accelerate ADME and environmental assessments—including metabolite ID and human mass balance studies—using expertly radiolabeled compounds in your development programs. Human ADME/Mass Balance under CGMP (Oral and IV sterile fill formulation) Microdosing/Phase 0 studies Lead optimization Preclinical ADME/PK under GLP certification Metabolite Identification - Metabolites in Safety Testing (MIST) Environmental assessment standards under GLP certification Applying 40-plus years of scientific expertise to all phases of drug development. This is where the photo caption goes for the graphic above. This is where the photo caption goes for the graphic above. This is where the photo caption goes for the graphic above.