API Synthesis Services
We provide rapid and comprehensive support for your early-phase drug development process, enabling you to establish 'critical mass' – in terms of personnel and know-how – in the chemical and analytical development of complex small-molecule drugs.
- Process research and development
- Full analytical method development and validation according to ICH guidelines
- Solid state development including salt screening and selection of optimal final salt formation and polymorphism study
- Synthesis of APIs for preclinical and clinical studies up to phase II
We deliver gram to kilogram quantities of your API required for preclinical to phase II clinical studies. This includes robust, scalable syntheses with purification and quality control procedures. Our offer includes the full GMP analytical package and help you to find the optimal solid-form properties for your drug substance.
Our partnership with RohnerChem closes the chain of services from route scouting through to commercial manufacturing.