Drug development consulting, Pharmacokinetics & Bioanalysis

We help successfully advance your R&D programs through focused discovery & development projects.

we can help your organization

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.

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

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

Over 8 programs covering discovery through Phase 2 development

Over 10 programs covering front and back of the eye indications

Over 4 programs in pediatric/orphan indications

About

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 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.

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

Learn How We Can Be Your Back Office Research Lab for your Biotech

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