Therapeutic Systems Research Laboratories

What Therapeutic Systems Research Laboratories does

Therapeutic Systems Research Laboratories (TSRL, Inc.) is a privately-held preclinical contract research organization (CRO) founded in 1986 and headquartered in Ann Arbor, Michigan. The company provides integrated drug development services to pharmaceutical, biotechnology, and academic teams, spanning bioanalysis (HPLC, LC-MS/MS), formulation development for oral, injectable, and transdermal routes, PK/ADME and toxicology studies, strategic consulting, and proprietary drug delivery technology including microarray patch (MAP) platforms. TSRL operates from a purpose-built 7,200 sq. ft. facility with 5,000 sq. ft. of wet lab space and an AAALAC-accredited vivarium, enabling in-house execution of IND-enabling preclinical workflows under GLP-aligned and ICH M10-aligned quality standards.

The business model is project-based fee-for-service CRO work, with custom pricing tied to each client's molecule, timeline, and regulatory objectives and multi-year contract cadences. Revenue is supplemented by non-dilutive funding from NIH SBIR grants; the company has secured nearly $20 million in such grants cumulatively, including a $2.2 million Phase II SBIR award in October 2025 to develop a weekly microneedle patch delivering Trospium Chloride for overactive bladder. In parallel, TSRL maintains a proprietary research and licensing pipeline that includes the hydrogel-based microneedle patch, a DNA-based antiviral program targeting adenovirus, and methionyl-tRNA synthetase inhibitors for MRSA. The company is led by President and CEO Dr. Elke Lipka (20+ year tenure), with the company originally founded by Dr. Gregory Amidon and supported by COO Dawn Reyna.

Customer relationships span a distributed base: enterprise pharmaceutical services (Velesco), early-stage biotech (Intero Biosystems, ONL Therapeutics, Odyssey Therapeutics, Diapin, Retro Sense), reagent and chemical suppliers (Cayman Chemical), federal research agencies (NIAID), and a long tail of academic institutions (University of Michigan, Michigan State, Purdue, University of Florida, University of Washington, Saint Louis University, SUNY Upstate, Utah State, University of Alabama Birmingham, SRI International). Distribution is direct: enterprise field sales through the website, phone outreach, and email inquiries routed to TSRL scientists. The company also participates in regional industry events such as the MichBio Drug Discovery and Development Symposium and has built co-development partnerships, most notably with Professor Ryan Donnelly at Queen's University Belfast for microneedle technology.

Name

Therapeutic Systems Research Laboratories

Legal name

TSRL, Inc.

Website

https://tsrlinc.com

Company type

Private

Founded year

1986

Operating status

Operating

Headcount range

11–50 employees

Short description

TSRL, Inc. is a privately-held preclinical CRO founded in 1986 in Ann Arbor, Michigan, providing integrated bioanalysis, formulation development, PK/ADME, toxicology, and drug delivery technology services to pharmaceutical, biotechnology, and academic teams progressing early-stage drug candidates toward IND-enabling milestones.

Ownership category

akta.pro rank

Product category

Preclinical Contract Research Services

NAICS

Scientific Research and Development Services (5417), Other Scientific and Technical Consulting Services (541690)

SIC

Laboratory Analytical Instruments (3826), In Vitro & In Vivo Diagnostic Substances (2835)

akta.pro primary industry

Randomization & Trial Supply Management (RTSM/IRT/IVRS/IWRS) (HLACAOAC)

Keywords

• Preclinical CRO services
• Drug formulation development
• Bioanalysis services
• PK/ADME studies
• Drug delivery technology

Headquarters

HQ city

Ann Arbor

HQ country

United States

HQ region

North America

Offices1 record

Markets served

GTM type

B2B

Offering type

Services

Cost components

Personnel, Operations, Infrastructure, Technology or R&D, Marketing or Sales

Revenue model

1. Contract Research Services: TSRL provides preclinical CRO services including bioanalysis, formulation development, PK/ADME and toxicology studies, and strategic consulting on a contract basis. Revenue is generated through project-based contracts with pharmaceutical, biotech, and academic clients.
2. Non-dilutive Grant Funding: The company secures NIH SBIR grants to fund internal research programs. TSRL has received multiple Phase II SBIR grants including a $2.2 million NIH grant for microneedle patch development.

Pricing tiers

Go-to-market motion1 record

Distribution channels1 record

Marketing channels5 records

Core offering

TSRL is a preclinical contract research organization that provides integrated drug development services spanning bioanalysis, formulation development, PK/ADME and toxicology studies, drug delivery technology support, and strategic consulting. The company combines wet-lab analytical work, an AAALAC-accredited vivarium, and formulation capabilities to help pharmaceutical, biotech, and academic teams progress early-stage drug candidates toward IND submission, while maintaining a proprietary pipeline of drug delivery and antimicrobial programs.

Product overview

TSRL, Inc. is a preclinical Contract Research Organization (CRO) providing integrated drug development services since 1986. The company offers a portfolio of five core service areas—Bioanalysis, Formulation Development, PK/ADME and Toxicology, Strategic Consulting, and Drug Delivery Technology—that work together to help pharmaceutical, biotech, and academic teams progress early drug candidates toward clinical development. Additionally, TSRL maintains a proprietary research and licensing pipeline including a microneedle patch program for overactive bladder, DNA-based antivirals for adenovirus, and tRNA synthase inhibitors for MRSA. The services are designed to be integrated, allowing cross-functional coordination across formulation, bioanalysis, and pharmacokinetic studies under one preclinical workflow.

Differentiator

Problem solved

Functional benefit

Products and services

• Bioanalysis Services Precision drug quantification and analytical support using HPLC and LC-MS/MS for pharmacokinetic, safety, and toxicology studies. Includes custom method development, validation, non-GLP and GLP analysis, and dosing solution analysis, targeted at pharmaceutical, biotech, and academic drug development teams.
• Formulation Development Services Tailored formulation strategies to improve solubility, stability, and drug delivery for oral, injectable, and transdermal routes. Includes excipient selection, preclinical stability testing, and technology transfer for clinical trial materials, targeted at pharmaceutical, biotech, and academic teams.
• PK/ADME and Toxicology Services Studies to assess how compounds are absorbed, distributed, metabolized, and eliminated. Includes in vitro ADME studies, metabolic stability testing, permeability and transporter studies, in vivo PK studies, and exploratory toxicology, targeted at pharmaceutical, biotech, and academic teams.
• Strategic Consulting Services Scientific guidance for early-stage development planning, compound profiling, dosing regimen development, translational input, data gap assessment, and non-dilutive funding guidance for biotech and pharmaceutical teams.
• Drug Delivery Technology Services Support for novel delivery systems including microarray patch (MAP) technology to address challenges with patient compliance, convenience, and compound stability, targeted at pharmaceutical and biotech teams developing innovative therapies.
• Microneedle Patch for Overactive Bladder (Trospium Chloride) Research and development program for a weekly microneedle patch using a hydrogel-based system to deliver Trospium Chloride for overactive bladder treatment. Developed with NIH funding to improve patient compliance and reduce side effects compared to traditional oral therapies.
• Antivirals | Adenovirus Program Internal DNA-based antiviral research program targeting adenovirus infections, part of TSRL's research and licensing pipeline.
• tRNA Synthase Inhibitors | MRSA Program Research program developing novel methionyl-tRNA synthetase inhibitors designed to target serious gram-positive hospital infections including MRSA. Part of TSRL's research and licensing pipeline, with associated publication activity in Microbiology Spectrum.

Quantifiable outcome

• Four Phase II SBIR grants funded simultaneously, placing TSRL in a very small percentage of female principal investigators nationally
• +1 more outcomes

Named customers4 records

Segments3 records

Ideal customer profiles3 records

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature6 records

Partnerships

Four partnerships are on record, tiered core and minor.

• Queen's University Belfast (Dr. Ryan Donnelly)coreStrategic or Co-development Partner · 1 August 2021Collaboration initiated in August 2021 with Professor Ryan Donnelly at Queen's University Belfast for microneedle technology development. TSRL CEO Dr. Elke Lipka traveled to Ireland to establish the partnership, which has led to joint development of microarray patch technology for drug delivery applications including overactive bladder treatment.
• DDF (Drug Development Forum)minorOthersPartner organization supporting drug development initiatives and the life sciences innovation ecosystem.
• Michigan Business Incubator AssociationminorOthersMichigan-based business incubator association supporting early-stage companies and innovation ecosystem development.
• MTRAC Innovation Hub for Life Sciences at University of MichigancoreStrategic or Co-development PartnerTSRL has leveraged MTRAC Innovation Hub for Life Sciences funding opportunities as part of its non-dilutive funding strategy and collaborative development approach with academic innovators.

Scale indicators6 records

Recent moves6 records

Expansion highlights6 records

Direct peers

• Frontage Laboratories: Integrated preclinical and clinical CRO offering bioanalysis, formulation development, and PK/ADME services to biotech and pharma sponsors. Highly comparable to TSRL's core service portfolio and customer base, though Frontage is significantly larger and publicly traded.
• Absorption Systems: Preclinical CRO historically specialized in ADME, permeability, and transporter studies for small molecules and biologics. Direct overlap with TSRL's PK/ADME service line and biotech customer segment; now part of Eurofins Discovery.
• Celerion: Early-stage clinical and preclinical CRO providing bioanalytical, ADME, and pharmacokinetic services to pharma and biotech. Comparable service mix and customer profile to TSRL, with similar focus on supporting IND-enabling programs.
• Avomeen: Analytical chemistry and formulation development CRO serving pharmaceutical, biotech, and medical device clients. Comparable in offering custom formulation and analytical services to small and mid-sized sponsors, similar scale and engagement model to TSRL.
• XenoTech (Sekisui Medical): Specialized CRO focused on drug metabolism, ADME, and in vitro pharmacology studies. Highly comparable to TSRL's PK/ADME and toxicology service line, with similar biotech/pharma customer base.
• Novum Pharmaceutical Research Services: Early-phase clinical and preclinical CRO offering bioanalytical, formulation, and PK services to biotech and generic pharma clients. Comparable niche positioning and service mix to TSRL.

Broad incumbents

• Eurofins Discovery: Large global CRO offering ADME, PK, bioanalysis, and drug discovery services across a much broader portfolio. Comparable capabilities to TSRL but at significantly greater scale and geographic reach.
• Charles River Laboratories: Largest preclinical CRO globally offering bioanalysis, formulation, PK/ADME, toxicology, and vivarium services. Overlaps with most of TSRL's service lines but serves a much larger and more diversified sponsor base.
• Labcorp Drug Development: Major CRO providing preclinical bioanalysis, PK/ADME, formulation, and toxicology services as part of a global drug development platform. Direct capability overlap with TSRL across most service lines, at much larger scale.
• WuXi AppTec: Global CRO/CDMO offering preclinical bioanalysis, formulation, PK/ADME, and toxicology services to pharma and biotech. Comparable service capabilities to TSRL with substantially broader scale and geographic footprint.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat5 records

Key risks6 records

Key highlights7 records

Customer concentration

• Xx.com/TSRL_Inc

Revenue estimate

Valuation estimate

Number of profiles

Profiles3 records

Funding overview

Funding rounds2 records

Investors2 records

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M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about Therapeutic Systems Research Laboratories