Eurofins CDMO leverages a wealth of experience in process chemistry. Our dedicated team is committed to delivering innovative and efficient solutions tailored to your unique needs from early-phase development to commercial manufacturing.
Our team is the backbone of our success. We ensure your projects receive maximum support from a dedicated team of cross-functional experts who are highly skilled at managing process development challenges within the biopharmaceutical sector. Our clients also leverage our technical expertise on phase-appropriate redevelopment programs to solve challenges with existing projects.
With extensive phase-appropriate support, we offer synthetic route redesign, process optimization, impurity synthesis and assessment, analytical method development and qualification, full structure characterization and elucidation, stress studies and ICH stability standards, and CMC gap analysis for commercialization.
Our facilities are Health Canada and FDA audited with fully-functional synthesis laboratories equipped with advanced instruments. Our state-of-the-art manufacturing suites also offer customizable technology platforms for the synthesis of advanced intermediates and New Chemical Entities (NCEs) / Active Pharmaceutical Ingredients (APIs).
Significant experience in commercializing FDA-designated fast track, breakthrough and orphan therapeutics, leveraging the experience and resources of the full organization (development, CMC regulation, manufacturing) to quickly advance programs from phase I immediately to commercial launch.