Analytical development

At Eurofins CDMO, we understand the pivotal role that analytical method development and validation play in drug development. Our network of companies offers a comprehensive suite of analytical services to support (bio)pharmaceutical companies throughout the drug life cycle, from pre-clinical to late-phase stages. 
Our analytical method development services encompass a wide range of capabilities, including method optimization, in-process controls, suitability testing, impurity characterization, and isolation. We work closely with our clients to establish suitable analytical methods, conduct method transfers, and carry out phase-appropriate method qualifications and full method validations. By leveraging cutting-edge techniques, we ensure precise and accurate results that meet regulatory requirements. 

Eurofins CDMO provides comprehensive CMC support, crucial for navigating the complex regulatory landscape. Our expertise in fate and purge studies, along with regulatory GAP assessments, enables us to identify potential challenges early and implement effective solutions. Additionally, we offer stability studies as per ICH guidelines, to assess the shelf-life and quality of your pharmaceutical products under different conditions.