Our pharmaceutical and bioanalytical team consists of Principal Investigators and Scientists with an average of 15+ years of experience in non-regulated and regulated bioanalysis with a focus on method development to accelerate your compound’s validation.  

You will also have full access to our Sample Management team to support the analysis of your studies in compliance with your in-life study, a Metrology team who can support in-house mass spectrometry maintenance, and a full Quality Assurance team with an impeccable 40+ year regulatory track record.

To talk to an expert about our Regulated Bioanalytical Services, please click here.

  • Sample Management and Sample Storage
  • Metrology and Instrument Qualification
  • Dose Formulation Analysis (DFA)
  • Stability Testing
  • In Vitro Bioequivalence Analysis
  • Bioavailability Analysis

  • Sample Management, Sample Storage, and Production of Custom Lab Sample Kits/Manuals
  • Metrology and Instrument Qualification
  • High-capacity GLP and GCP LC-MS/MS Method Development and Validation
  • Multiple Sample Treatment Procedures
    • Protein precipitation, solid phase extraction (SPE), and liquid-liquid extraction techniques
  • Pharmacodynamic (PD) Sample Analysis
  • Pharmacodynamic (PD) Biomarkers
  • Pharmacokinetic (PK) and Toxicokinetic (TK) Sample Analysis
  • Tissue Sample Preparation and Sample Analysis
  • Clinical Kit Assembly
  • Bioanalytical Support for Domestic and International Studies
  • Preclinical and Clinical Studies for Safety and Efficacy
  • Immunogenicity
  • Bioequivalence
  • Pharmacokinetics
    • Phoenix® WinNonlin®
    • Noncompartmental analysis
  • Small Molecules by LC-MS/MS
    • Proprietary and Nonproprietary Drugs
    • Prodrugs
    • Insecticides
    • Synthetic analogues
    • Inhibitors
    • Metabolites
    • Chemotherapeutics
    • Anesthetics
    • Antiandrogens
    • Hormones
    • Immunosuppressives
    • Vaccines
  • Large Molecules or Biologics by LC-MS/MS
    • Proteins
    • Peptide(s)
    • Oligonucleotides
    • Nucleic acids
  • Animal and Human Biological Substances
    • Plasma, serum, whole blood, urine, bile, saliva, tears, cerebrospinal fluid, etc.
  • Milk
  • Dried Blood Spots
  • Tissues with Homogenization
    • Animal specialties (canine, minipig, mouse, porcine, rabbit, rat, and non-human primates) and tissue types:
      • kidney, lung, brain, muscle, spleen, coronary band, artery, etc.
  • Microdialysate
  • In Vitro:
    • Hepatocyte
    • Media

Inotiv’s bioanalytical solution supports your program from preclinical research through clinical development. We are here to help you by delivering actionable insights with on-time results to move you to the next milestone. Our GLP nonproprietary methods have been validated in accordance with U.S. FDA Crystal City and current regulatory guidelines. You’ll benefit from our expert scientific team and state-of-the-art technologies to support your investigation into drug-drug interactions, concomitant drugs, and generics studies.

To talk to an expert about our nonproprietary methods, please click here.

  • Liquid Chromatography, Tandem Mass Spectrometry
    • AB SCIEX™ Platform (4000, 5500, 6500, 7500)
  • Bio-Automation
    • TomTec Quadra 96 Liquid Handling System
    • Hamilton Microlab STAR Liquid Handling System
    • TubeWriter™ 360
    • SPEX SamplePrep 2010 Geno/Grinder Cell Lyser and Homogenizer
  • HPLC and UPLC systems:
  • Shimadzu Nexera®
  • Agilent®
  • Waters™
  • CTC and Shimadzu Multi-Plate Autosamplers
  • UV-Vis, fluorescence, electrochemical, charged aerosol detectors
  • SpectraMax® M5 Microplate Readers (Vis, UV, Fl)
  • Watson LIMS™ 7.5 SP1
  • Projects Database System – Project Life Cycle Management
  • Chromeleon™ Data Acquisition for HPLC
  • Sciex Analyst®
  • SoftMax® Pro GxP
  • PerkinElmer® ELN
  • MasterControl™ Document/Training Management System
  • 21 CFR Part 11 Compliant