About

About TSRL, Inc. Beyond Testing: Your Strategic Partner for Preclinical Product Development Success The transition from early-stage research to clinical drug development is one of the most challenging phases in the pharmaceutical industry. Many promising drug candidates fail due to insufficient preclinical data, lack of strategic guidance, and funding limitations. At TSRL, Inc., we have built a strong reputation as a preclinical accelerator, helping biotech startups and academic researchers bridge this critical gap as an early-stage funding partner and pharmaceutical product development advisory team. Now, we are expanding our role by offering comprehensive Contract Research Organization (CRO) services, providing the scientific expertise, technical capabilities, and operational support to advance drug candidates toward clinical trials efficiently. Our mission is to provide high-quality preclinical testing that supports regulatory submissions, de-risks development pipelines, and accelerates drug product candidates toward clinical success. 1. Comprehensive 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. 2. 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. 3. Innovative Drug Delivery Technologies Alongside our services, TSRL is advancing next-generation drug delivery technologies to improve therapeutic efficacy and patient outcomes. MicroArray Patch (MAP) Technology Our MAP formulations provide a self-administered drug delivery system that avoids the inconvenience of traditional injections. This hydrogel-based microarray: Provides a drug-releasing reservoir upon skin application Delivers therapeutics directly into systemic circulation Reduces the need for clinic visits and improves patient compliance MAP technology represents a delivery alternative for suboptimal drug products, improving bioavailability, consistency of dosing, and ultimately patient compliance. Prodrug Platform: Enhancing Oral Drug Absorption TSRL’s patent-protected prodrug technology is designed to increase membrane permeability and improve oral bioavailability of challenging compounds. This platform: Optimizes drug absorption in the GI tract Reduces variability in drug exposure Provides a strategy for targeted delivery Minimizes side effects while enhancing therapeutic efficacy This approach has the potential to improve the pharmacological profile of drug candidates, making them more clinically viable and commercially attractive. 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. Beyond Testing: Your Strategic Partner for Preclinical Product Development Success The transition from early-stage research to clinical drug development is one of the most challenging phases in the pharmaceutical industry. Many promising drug candidates fail due to insufficient preclinical data, lack of strategic guidance, and funding limitations. At TSRL, Inc., we have built a strong reputation as a preclinical accelerator, helping biotech startups and academic researchers bridge this critical gap as an early-stage funding partner and pharmaceutical product development advisory team. Now, we are expanding our role by offering comprehensive Contract Research Organization (CRO) services, providing the scientific expertise, technical capabilities, and operational support to advance drug candidates toward clinical trials efficiently. Our mission is to provide high-quality preclinical testing that supports regulatory submissions, de-risks development pipelines, and accelerates drug product candidates toward clinical success. 1. Comprehensive 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. 2. 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. 3. Innovative Drug Delivery Technologies Alongside our services, TSRL is advancing next-generation drug delivery technologies to improve therapeutic efficacy and patient outcomes. MicroArray Patch (MAP) Technology Our MAP formulations provide a self-administered drug delivery system that avoids the inconvenience of traditional injections. This hydrogel-based microarray: Provides a drug-releasing reservoir upon skin application Delivers therapeutics directly into systemic circulation Reduces the need for clinic visits and improves patient compliance MAP technology represents a delivery alternative for suboptimal drug products, improving bioavailability, consistency of dosing, and ultimately patient compliance. Prodrug Platform: Enhancing Oral Drug Absorption TSRL’s patent-protected prodrug technology is designed to increase membrane permeability and improve oral bioavailability of challenging compounds. This platform: Optimizes drug absorption in the GI tract Reduces variability in drug exposure Provides a strategy for targeted delivery Minimizes side effects while enhancing therapeutic efficacy This approach has the potential to improve the pharmacological profile of drug candidates, making them more clinically viable and commercially attractive. 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.