Preclinical Testing Services

Our AAALAC-accredited research facility in Ann Arbor, MI, is equipped with a vivarium and advanced instrumentation, including HPLC, LC-MS/MS, and spectrophotometry, allowing us to deliver precise, high-quality data to our clients.  All studies are conducted in compliance with TSRL SOPs and client-approved protocols and undergo rigorous quality control to ensure accurate and reproducible results.

Bioanalysis: Precision Drug Quantification

Accurate quantification of drug exposure is critical for determining efficacy, safety, and dosing strategies. TSRL’s bioanalytical services include:

  • HPLC and LC-MS/MS quantification of drugs and metabolites

  • Method development and validation for bioanalytical assays

  • Non-GLP preclinical and clinical sample analysis

Our advanced analytical capabilities are customizable to support everything from early-stage research to ICH M10 compliance, providing high-quality data for regulatory filings and clinical trial preparations.

Formulation Development: Optimizing Drug Delivery

One of the biggest hurdles in drug development is ensuring effective drug delivery. TSRL’s formulation development services focus on enhancing bioavailability, stability, and manufacturability through:

  • Solubility screening and optimization

  • Formulation screening for oral, injectable, and transdermal delivery

  • Preclinical formulation stability testing

We develop tailored drug formulations that improve performance and meet target profiles.

PK/ADME & Toxicology: Understanding Drug Behavior

  • In vitro ADME (absorption, distribution, metabolism, and excretion) profiling

  • Blood/plasma stability and protein binding assays

  • Microsomal, hepatocyte, and intestinal metabolism studies

  • In vivo PK studies in rodents

  • Mechanistic absorption studies

  • Exploratory toxicology

  • Biodistribution and exposure assessments

Early-stage pharmacokinetic and toxicology insights support candidate selection, optimize dosing strategies, and reduce risk prior to clinical development.

Strategic Consulting & Regulatory Guidance

As TSRL expands its CRO offerings, we continue to provide high-level strategic guidance to ensure drug candidates meet regulatory and clinical development milestones. Our consulting expertise includes:

  • Regulatory Strategy Development – Ensuring preclinical studies align with FDA/EMA guidelines

  • Clinical Planning – Designing data-driven clinical trial strategies

  • Intellectual Property Strategy – Strengthening patents and licensing assets

  • SBIR Grant Strategy – Strengthening the small business funding pipeline

TSRL combines scientific rigor with strategic planning to optimize preclinical programs for regulatory approval and market success.

The TSRL Advantage: A CRO Partner That Goes Beyond Testing

TSRL is positioned as a full-service preclinical partner that goes beyond traditional contract research. Unlike many CROs that only offer testing and data generation, we provide end-to-end drug development support, helping clients:

✔ Secure non-dilutive funding for early-stage development
✔ Generate high-quality preclinical data to support IND applications
✔ Optimize drug formulations and delivery methods
✔ Develop regulatory strategies to streamline approval processes

Whether you are a biotech startup, pharmaceutical company, or academic research team, TSRL’s expanded CRO capabilities provide the scientific expertise, technical resources, and strategic insight needed to accelerate drug candidates from discovery to clinical trials.

Ready to streamline your drug development process? Get in touch at BD@tsrlinc.com or visit www.tsrlinc.com.