Phase I
Eurofins CDMO offers support for Phase I, as well as integrated end-to-end drug development services for your drug development pathway.
50% of our projects are linked to pre-clinical and phase I studies
We have extensive experience in material characterization, analytical chemistry and strategies for developing poorly soluble compounds. Our Pre-Formulation laboratory is fitted with a suite of specialized equipment focused on solubility, absorption and In-Vitro/In-Vivo correlation studies. Our formulation development lab and pilot plant suites are specifically designed for high containment and outfitted with cGMP matching technologies. Our state-of-the-art facilities and cGMP compliant systems are specifically designed for quick-to-clinic operations.
Eurofins CDMO’s team of Engineers, Technology Transfer specialists, and Scientists specialize in process transfer and scale-up strategies, providing a seamless transition of programs from development through cGMP manufacturing.
Our Capabilities Include:
- Solvents & Polymorph Studies
- Route Development & Process Optimization
- Reference Standards, Impurities
- Critical Process Parameters
- Comprehensive Solid Form Studies
- Staged Analytical Method Validation & Forced Degradation and Stress Studies
- Stability Studies (Accelerated, Intermediate, Long Term for a range of test attributes and regions)
- Pre-formulation Studies
- Formulation Development
- cGMP Drug Substance & Drug Product Manufacturing
