Preclinical Studies to Drive Forward Drug Development Insights
Advance your drug product through preclinical research and formulation with support from our expert team. Whether you face challenges with your dosing vehicle or simply need preclinical dosing supplies, our team is here to help.
Preclinical drug development is unique to each program. Before advancing to analytical, clinical formulation, and process development, we establish a foundational data package for you to inform which drug candidate(s) you should consider moving forward and prepare you for upcoming CMC development activities.
Preclinical Development Services
With years of experience in early-stage development, we understand your challenges, such as limited API. We have the capabilities to perform experiments with small amounts of API to conserve resources. We then utilize our range of experience to develop the dosage form, from solutions/suspensions to intrathecal. By working closely with you and your dosing partner, our team ensures preparation instructions are clear and project handoff is smooth.
Dosing Vehicles
We formulate your active pharmaceutical ingredient (API) with generally regarded as safe (GRAS) excipients when practical, focusing on the species, route of administration, and goals of the preclinical experiment. During early stages of a project, goals may involve conducting an ADME/pharmacokinetic study, assessing safety/toxicology, or creating a clinical formulation.
Test Articles
We prepare, test, and ship your preclinical test articles, whether or not your formulation requires specialized technology for preparation or not. Our team is well prepared to support your test article preparation, from simple suspensions to sterile materials.
Analysis
We tailor our preclinical formulation analysis strategy to your specific project needs and end goals. From minimal appearance testing to more complete characterization, our team finds a solution fit specifically for you.
Drug Approval Pathways
Preparing a cohesive submission to a regulatory agency requires a calculated approach and extensive authoring. Our consulting team is here to help shape your research and development into a cohesive, strategic submission to regulatory agencies.
Diverse Molecular Support
Small Molecules
Achieve important milestones by partnering with our team to identify molecular candidates with the best chances of success, providing crucial insights for confident decision-making.
Biologics
Power your project with informed decision-making through comprehensive analysis supported by our team.
Nucelic Acids
Establish a comprehensive foundation for your nucleic acid-based therapeutic with help from our highly experienced team.
Novel Molecules
Break away from traditional approaches to pharmaceutical development with support from our expert team.