YOUR Back Office Lab for Your Biotech

We help successfully advance your R&D programs through rational, decision-based, and 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 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:

  • Regulatory strategy
  • Development Strategy and Writing for Type B and Type C FDA meetings
  • Nonclinical pharmacology
  • Small molecule and large molecule method development, qualification and validation
  • Nonclinical ADME/PK
  • Metabolite profiling, identification and program development strategy
  • Clinical Pharmacology/PK
    IND, NDA Writing, Advisory Committee, Preparation and Participation
  • Phase 1 Clinical Study Design
  • Incorporation of Clinical PK into Phase 2 programs
  • Nonclinical Study Monitoring
  • Phase 1 Clinical Trial Monitoring

We Offer Research Services in:

We offer Regulated and Quality Controlled Services in:

  • Nonclinical GLP Toxicokinetics (TK) Analysis and Reporting
  • CDISC Nonclinical PP and PC SEND Domains
  • Clinical PK Analysis and Reporting
  • CDISC Clinical PP and PC SDTM Domains

We Support Your Compound Procurement, Storage, and Distribution

  • Procurement of small and large quantities of research grade small molecules not readily available or cost prohibitive from traditional vendors
  • Oversight of contract medicinal chemistry manufacturing of research program small molecules and metabolites
  • Long Term Frozen storage of small quantities of your research grade API
  • Sample Aliquoting and Shipping to Research Collaborators
  • Tracking and Monitoring of API Usage

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.

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 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

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

We are here to assist. Contact us by phone, email, or via our social media channels.