We are a boutique, client focused, contract research and consulting organization with a focus on 505(b)(1) and 505(b)(2) early drug discovery, nonclinical development, clinical pharmacology/PK and regulatory submissions. Click on the titles to learn more.
Nonclinical ADME/PK, Bioanalysis and Clinical Pharmacology/PK is therapeutic area agnostic. However, that doesn’t mean that Xyzagen doesn’t have focused experience in certain therapeutic areas. Xyzagen’s staff has worked in the following areas listed below for over 2 decades. Some general statistics on some of the programs, which does not include numerous PreIND, EOP2, NDA and Type C Face-2-Face meetings and conference calls.
Over 5 programs covering Discovery, IND, Phase 2, and NDA programs
Over 5 programs covering bench to Phase 2 as well as post approval biopharmaceutics tech transfer
Worldwide approval of Potiga/Trobalt and over 15 other programs covering Discovery though IND/NDA submissions
We support clients ranging from early stage seed funded companies emerging from academia, recently venture backed biotechs, to mid/large pharmaceutical companies. Additionally, we act as a 3rd party bioanalytical, pharmacokinetics/toxicokinetics site to other contract research organizations (CROs). We support our clients in every step of the pharmaceutical discovery and development process from early compound discovery PK screening to nonclinical PK/PD studies and Phase 1-2 clinical pharmacology/PK drug development. Our broad focus in pharmacokinetics and development ensures that your development plan supports your corporation’s goals.