Eurofins Amatsigroup
Eurofins Amatsigroup: your CDMO partner for full drug development
Biological and chemical entities
Eurofins Amatsigroup is part of Eurofins CDMO and based in Europe. Our company focuses on drug product development for chemical / biological entities and drug substance development for biologics.
We support small and major biopharmaceutical companies in an innovative way to help them achieving their (pre)clinical milestones timely.
Our solid track record in developing and manufacturing Biological & Chemical Entities is one of our strongest asset.
We are experts in breakthrough technologies for highly potent compounds, poorly soluble drugs, lyophilisation processes and specific therapeutic areas (immunotherapies, orphan drugs, pediatric dosage forms…). Our GMP facilities are perfectly designed for small clinical and/or commercial batches either for sterile or non-sterile dosage forms.
Involved in the earliest steps, our highly-qualified project management team will propose a complete drug development strategy in compliance with regulations.
Frequent communication through one single point of contact, flexibility, troubleshooting mindset, customized solutions, will help our clients to speed up their drug development process. Our goal is to build a sustainable partnership with our customers to support their drug development pathway.
Choose Eurofins Amatsigroup to help you:
✔ Accelerate pre-clinical and clinical phases of your product with easy scale-up and smooth transfer from development to GMP facilities, including fill & finish suites (manufacturing under isolator and single-use material).
✔ Navigate complex formulation screening and development with a vast array of innovative technologies.
✔ Enhance bioavailability of poorly soluble drugs and controlling drug release.
✔ Develop and validate stability indicating methods, as well as stability evaluation of drug substances and developed drug products, including Accelerated Stability, ICH Stability, In-Use Stability, and Accelerated Stability Assessment Programs (ASAPs).
✔ Perform clinical trial manufacturing of non-sterile and sterile drug products.
✔ Perform commercial manufacturing (small commercial batches and orphan drugs).
✔ Ensure regulatory support throughout the complete development pathway.
