Preclinical: IND/CTA Enabling

IND- and CTA-enabling studies comprise preclinical pharmacology and manufacturing studies. These allow you to submit a formal application with the FDA or EMA. We accelerate the development of your medicines, de-risk your program, and reduce time to market by leveraging the extensive experience of our scientific and regulatory affairs experts.

We design and deliver tailored solutions across a comprehensive suite of services including, cell line development, formulation development, analytical method development and process development.