Pre-clinical Phase
Partnering with Eurofins CDMO (Contract Development & Manufacturing Organization) during the preclinical phase of your research ensures that you have the access to resources and expertise which takes your API from the lab to the plant.
100s of compounds for pre-clinical & clinical phases have been developed by us
We focus on process chemistry, cGMP scale-up and analytical method development for complex, small molecule APIs including highly potent molecules. We have supported clients from pre-clinical phase through IND development, into late phase and commercial activities.
Our Capabilities Include:
- Route scouting – development of new, scalable API route options
- Process safety and hazards assessment
- cGMP starting material assessment & establishment of regulatory concept
- Starting material & other raw materials sourcing and development
- Polymorph screening & salt selection
- Analytical method screening, validation & stability studies
- Impurity isolation and characterization
- Pre-formulation & pre-clinical supply
- GLP API synthesis
- GMP API synthesis
