Toxicology Solutions

Name

Toxicology Solutions

Legal name

Toxicology Solutions, Inc.

Website

https://toxsolutionsinc.com

Company type

Private

Founded year

2012

Operating status

Operating

Headcount range

1–10 employees

Short description

Toxicology Solutions is an independent consulting firm providing nonclinical toxicology, DMPK, and genotoxic and nitrosamine impurity risk assessment services to small and mid-cap biopharma sponsors.

Ownership category

akta.pro rank

Product category

Pharmaceutical Toxicology Consulting

SIC

Services-Commercial Physical & Biological Research (8731)

akta.pro primary industry

In Silico / Computational Toxicology & PK/PD Modeling (HLAGAFAM)

akta.pro secondary industries

Toxicology & Safety Assessment CROs (GLP) (HLAGAAAC), Carcinogenicity Studies (HLAGAFAG)

Keywords

• Nonclinical toxicology services
• DMPK consulting services
• Genotoxic impurity evaluation
• In silico toxicity prediction
• Regulatory submission support

Headquarters

HQ city

San Diego

HQ country

United States

HQ region

North America

Offices2 records

Markets served

GTM type

B2B

Offering type

Services

Cost components

Personnel, Operations, Marketing or Sales, Others

Revenue model

1. Scientific and Strategic Consulting Services: Project-based consulting engagements providing toxicology and DMPK services to pharmaceutical companies. Services include nonclinical toxicology program support, in silico toxicity predictions, GLP PK/TK reports, regulatory submission support, and strategic consulting for drug development programs.

Go-to-market motion1 record

Distribution channels1 record

Marketing channels4 records

Core offering

Toxicology Solutions is an independent consulting company providing nonclinical toxicology and Drug Metabolism and Pharmacokinetics (DMPK) services to the pharmaceutical industry. Its offerings span GLP-compliant toxicokinetic (PK/TK) analyses, in silico (Q)SAR-based genotoxic impurity evaluations under ICH M7, Carcinogenicity Potency Categorization Approach (CPCA) assessments for N-nitrosamines, study planning and CRO oversight for GLP toxicology studies, risk assessment/occupational health evaluations, and regulatory submission support for INDs, NDAs, and CTD modules.

Product overview

Toxicology Solutions is an independent consulting company providing toxicology and DMPK (Drug Metabolism and Pharmacokinetics) services to the pharmaceutical industry. Their portfolio consists of six interconnected service offerings: DPMK services (GLP PK/TK analysis, pharmacokinetic analysis, human dose prediction), Genotoxic Impurities Evaluation (computational toxicology/QSAR analysis per ICH M7), CPCA for N-nitrosamine evaluation, Toxicology Services (study planning, CRO coordination, GLP studies), Risk Assessment and Occupational Health (PDE/ADI determinations), and Regulatory Support (FDA/EMA submissions). The company merged with ADME Solutions in 2021 to provide comprehensive nonclinical safety assessment services.

Differentiator

Problem solved

Functional benefit

Products and services

• DMPK (Drug Metabolism and Pharmacokinetics) Services Comprehensive DMPK services for pharmaceutical drug development including GLP toxicokinetic analysis and report writing, general ADME strategy, pharmacokinetic analysis, human dose/PK prediction, clinical PK analysis, regulatory submission writing, and due diligence assessments.
• Genotoxic Impurities Evaluation Computational toxicology evaluations conducted in accordance with ICH M7 guidance using (Q)SAR analysis with DEREK, Leadscope, and MultiCase software.
• CPCA for Evaluation of N-nitrosamines Carcinogenicity Potency Categorization Approach service for N-nitroso compounds in accordance with FDA 2023 guidance.
• Toxicology Services Toxicology study planning, strategy, protocol development, CRO coordination, and on-site study monitoring across GLP study types.
• Risk Assessment and Occupational Health Determination of PDE/ADI values, occupational health categorizations, and SDS writing.
• Regulatory Support Regulatory submissions (INDs, NDAs, CTD modules, Investigator Brochures) and meeting support for FDA, EMA, and Japan.

Quantifiable outcome

• Scientists have worked on numerous INDs and NDAs spanning various therapeutic areas, routes of administration, and species
• +1 more outcomes

Named customers5 records

Segments3 records

Ideal customer profiles2 records

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

AI capability3 records

Feature4 records

Partnerships

One partnership is on record.

• ADME Solutions, Inc.coreStrategic or Co-development Partner · 1 October 2016ADME Solutions, Inc. was founded by Dr. Archie Thurston in October 2016. Toxicology Solutions and ADME Solutions have been affiliated partners since inception of ADME Solutions in 2016. The companies provided complementary services as toxicology and ADME are critical components of nonclinical safety packages. They officially merged into Toxicology Solutions, Inc. effective July 1, 2021.

Scale indicators3 records

Recent moves5 records

Expansion highlights4 records

Broad incumbents

• WuXi AppTec: Global CRO/CDMO with significant toxicology, DMPK, and bioanalytical services. Comparable through its nonclinical safety and DMPK service lines serving small and large pharma, though vastly broader in scope.
• Pharmaron: Integrated CRO offering DMPK, safety assessment, and regulatory support to pharma and biotech. Comparable through toxicology and DMPK offerings, with similar IND/NDA submission support but at much larger scale and broader geographic reach.
• Labcorp Drug Development (Covance): Large CRO offering end-to-end nonclinical safety, DMPK, and regulatory services globally. Comparable in providing toxicology, PK/TK, and submission support, but bundled as part of a broad clinical and central lab portfolio.
• Charles River Laboratories: Global full-service CRO with extensive nonclinical toxicology, DMPK, and regulatory capabilities. Comparable as the dominant incumbent in the same service categories TSI serves, though operating at vastly greater scale across the full preclinical workflow.
• Eurofins Discovery: Discovery and preclinical services arm of Eurofins offering ADME/PK and toxicology services. Comparable in providing DMPK and computational toxicology within a broader discovery-services portfolio to pharma clients.

Direct peers

• Cyprotex (Evotec): Specialized ADME/DMPK and in silico toxicology CRO, now part of Evotec. Comparable through its DMPK and computational toxicology capabilities including in silico genotoxicity prediction aligned with ICH M7.
• ITR Laboratories Canada: Canadian preclinical CRO specializing in toxicology, safety pharmacology, and DMPK studies. Comparable as a niche-focused nonclinical safety services provider with a similar GLP-anchored offering and small-to-mid biotech client base.
• Seventh Wave Laboratories: St. Louis-based preclinical CRO providing toxicology, PK, and ADME services to pharma and biotech. Directly comparable as a specialized small/mid-sized toxicology and DMPK services firm; notably, Dr. Archie Thurston (TSI's COO) previously served as Manager of PDM at Seventh Wave.
• Experimur (Toxikon): Preclinical toxicology and contract research firm offering GLP toxicology and DMPK services. Comparable in service mix (nonclinical toxicology, GLP studies, regulatory support) and target clients (pharma and biotech programs).
• ApconiX: UK-based specialist toxicology and ion channel consulting firm serving pharma clients. Comparable as a boutique toxicology consultancy focused on nonclinical safety assessment and regulatory support, similar in scale and senior-expert delivery model.

Market position

Strengths4 records

Weaknesses4 records

Competitive moat4 records

Key risks5 records

Key highlights6 records

Customer concentration

• LinkedInlinkedin.com/company/toxicology-solutions-inc

Revenue estimate

Valuation estimate

Number of profiles

Profiles4 records

Funding overview

Funding rounds

Investors

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Investments

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

Frequently asked questions about Toxicology Solutions