Expert 14C radiolabeling for human clinical programs requires extensive training and experience. Having supported radiolabeled studies for more than 30 years, ABC Laboratories was one of the first to produce 14C-labeled API and formulate CTMs under CGMP requirements. 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 CTM, 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 while supplying high quality products and data. ABC maintains a dedicated Quality Control and Quality Assurance staff with extensive experience specifically supporting isotopically labeled compounds. Nowhere will you find a team with more skill in developing efficient synthetic routes, commitment to delivering your labeled drug candidate, batch records and Certificates of Analysis in the agreed-upon time at the level of quality needed to meet today's high standards.
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