Regulatory-ready methods from first-in-human through registration.
Inotiv provides end-to-end clinical bioanalysis and biomarker support to help you advance confidently from early clinical studies through registration. Our methods are developed and validated to ICH M10, FDA, and EMA guidance, ensuring high quality, defensible data for regulatory submissions.
Our scientific teams support a wide range of modalities and endpoints, including:
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Pharmacokinetics (PK)
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Immunogenicity
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Biomarkers: Small molecule (LC MS/MS), large molecule (ligand binding or hybrid LC MS/MS), targeted proteomics including Target Sufficiency®, vaccine endpoints, multiplex panels, drug-drug interaction, metabolite identification, and multi domain modalities
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Flow cytometry: Custom panel design, phospho flow, receptor occupancy, immunophenotyping
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Advanced analysis & interpretation: Noncompartmental PK (Phoenix WinNonlin®), PK modeling, CDISC SDTM PC/PP domains, mechanistic and computational toxicology, biosimilar support
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Clinical kits: Protocol specific collection kits, laboratory manuals, site training materials, sample custody and storage
Whether you’re developing small molecules, peptides, monoclonal antibodies, bispecifics, oligonucleotides, or antibody drug conjugates, our scientists deliver the clarity and confidence needed to move your program forward.
Complete the form to request a copy of our Clinical Bioanalysis & Biomarkers overview.
