The Aragen preformulation team is experienced in developing technologies to support efficacy, PK and toxicology studies in different species. With strong expertise in solid form optimization and formulation development, we select appropriate solid forms and recommend preclinical formulations. Our preformulation, biology, chemistry and DMPK teams collaborate to provide integrated solutions. We use relevant scientific data to predict and assess developability of new chemical entities (NCEs) with minimal quantities of drug substance, to achieve faster to clinic milestones.
Preformulation Solutions
A comprehensive range of solutions to develop and supply formulations for toxicology studies.
Strong analytical skills in method development and validation, and a quality by design (QbD) approach, to facilitate speedy IND/NDA filing.
Reliable and reproducible analytical data to support speedy filing for regulatory approval.
