Reliable data for confident decisions

High‑quality pharmacokinetics / toxicokinetics (PK/TK) analytics that keep your clinical program moving forward.

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Comprehensive PK/TK capabilities

Our PK/TK capabilities support small molecules, biologics, vaccines, cell and gene therapies, and complex modalities across preclinical through Phase I–III studies. Current services include:

  • Quantitative ligand‑binding assays (ELISA, ECL) for PK/TK analysis

  • PK/TK method development, qualification, and validation

  • Multi‑matrix expertise (plasma, serum, tissues, swabs, BAL, CSF, and others)

  • High‑throughput platforms for rapid sample processing

  • Phase‑appropriate documentation and regulatory‑ready deliverables

Planned expansion: Our LC‑MS/MS platforms are under active development now, with availability targeted for Q1 2027 to provide a full suite of mass spectrometry solutions.

Expert method development & validation

Our scientific team brings deep experience in PK/TK assay design and validation that withstands regulatory scrutiny.

Capabilities include:

  • Custom method development for novel drug candidates

  • Selectivity, sensitivity, stability, and recovery optimization

  • Cross‑matrix bridging

  • Comprehensive validation aligned with FDA, EMA, and ICH expectations

  • Scientific interpretation and data consulting throughout development

Whether using ligand‑binding assays today or LC‑MS/MS methods launching in 2027, our approach remains consistent: rigor, reliability, and full regulatory alignment.

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Evolving instrumentation strategy

While our ligand‑binding infrastructure currently supports a broad set of PK/TK programs, we are investing strategically in expanded analytical capability.

Available now

  • Electrochemiluminescence (ECL) ligand‑binding platforms

  • Automated sample preparation

  • Robust workflows for biologics, vaccines, complex matrices, and exploratory biomarkers

Coming Q1 2027

  • High‑sensitivity LC‑MS/MS systems

  • Hybrid LC‑MS platforms for complex analytes

  • Automated extraction workflows designed to increase throughput and efficiency

These additions will enable fully integrated PK/TK support across small molecules, biologics, and advanced modalities.

Fast, reliable turnaround

Your timelines shape our workflows. We provide:

  • Accelerated method development

  • Prioritized sample analysis options

  • Automated, high‑throughput platforms

  • Predictable turnaround time across every project

Our operational model is built to support rapid PK/TK decision‑making in early- and late‑phase trials.

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Deep expertise across modalities

We support a broad range of therapeutic categories:

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Cell therapies
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Vaccines
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Gene Therapy
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Monoclonal antibodies and biologics
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Microbiome and live biotherapeutic products
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Small molecules

(via ligand‑binding assays now; LC‑MS/MS capabilities coming 2027)

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Why partner with us

Growing capabilities to support future needs
We deliver full ligand‑binding PK/TK services today, with LC‑MS/MS expansion in Q1 2027 – positioning us to support the full spectrum of therapeutic modalities.

Strength in high‑complexity programs
We’re known for tackling difficult matrices, low‑abundance analytes, unique biotech constructs, and emerging therapeutic platforms.

Speed + scientific rigor
Our automated workflows and experienced scientific team deliver fast, consistent results without sacrificing quality.

Expert scientific partnership
Sponsors rely on us for strategic guidance, method optimization, troubleshooting, and data interpretation – not just numbers on a report.

Scalable capacity
Our infrastructure supports rapid early R&D studies through large, global, late‑phase programs – with expansion continuing ahead of sponsor demand.