We help successfully advance your R&D programs through rational, decision-based, and focused discovery & development projects.
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 pharmacology & pharmacokinetics, clinical pharmacology/PK and regulatory IND/NDA strategy, submission writing & consulting. Click on the titles to learn more.
We Offer Consulting Expertise and Oversight in:
We Offer Research Services in:
We offer Regulated and Quality Controlled Services in:
We Support Your Compound Procurement, Storage, and Distribution
Xyzagen has drug development expertise in the therapeutic areas of Anti-Infectives, Cardiology, Neurology, Ophthalmology, Pain, and Pediatric/Orphan Indications
Unlike Clinical Development, where it’s necessary to be a medical expert, 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
Xyzagen has drug development expertise in the therapeutic areas of Anti-Infectives, Ophthalmology, Neurology and Pain
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 pharmacokinetics/toxicokinetics analyst to other contract research & consulting organizations (CRCOs). 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; ensuring that your development plan supports your corporation’s go/no go decisions.
We are here to assist. Contact us by phone, email, or via our social media channels.