WHO IS XYZAGEN
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.
WE KNOW WHAT WE’RE DOING
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.
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.
OUR EXPERIENCE SPEAKS FOR ITSELF
Over (200) two hundred small molecule bioanalytical methods developed
Over (100) one hundred nonclinical PK studies analyzed and reported
Over (40) forty GLP toxicokinetic (TK) studies analyzed and reported
Over (25) twenty five Clinical Pharmacology/PK study analyzed and reported
Over (20) twenty bioanalytical methods developed and validated
Over (15) fifteen 505(b)1 and 505(b)2 PreIND meetings
Over (12) twelve 505(b)1 and 505(b)2 IND submissions
Over (10) ten 505(b)1 and 505(b)2 NDA submissions
Over (8) eight end-of-phase 2 meetings
One (1) FDA Advisory Committee Meeting
TALK TO US TO SEE HOW WE CAN BE YOUR BACK OFFICE RESEARCH LAB FOR VIRTUAL BIOTECH
