Scantox
Scantox offers biocompatibility testing services, leveraging extensive archives of biomedical and life sciences literature for research and compliance.
Scantox provides specialized biocompatibility testing, drawing upon a vast digital archive of biomedical and life sciences journal literature. This resource, maintained by the U.S. National Institutes of Health's National Library of Medicine (NIH/NLM), ensures access to centuries of scientific research crucial for understanding and validating the safety of medical devices and materials. Our services are designed to support organizations in navigating the complexities of regulatory compliance and scientific validation. By utilizing comprehensive data and research, Scantox aims to deliver reliable and accurate biocompatibility assessments, contributing to the advancement and safety of life sciences innovations.
About
**Who they are**
Scantox is a Contract Research Organization (CRO) specializing in toxicology and preclinical research, with a focus on supporting drug development from early stages through to regulatory submissions.
**Expertise & scope**
* Offers a comprehensive suite of toxicology services, including GLP-compliant studies, for preclinical drug development.
* Conducts general toxicology studies using rodent and non-rodent models, including Maximum Tolerated Dose (MTD) and Dose Range Finding (DRF) studies, as well as repeat-dose toxicity studies (e.g., 4-week, 13-week, 26-week, and 39-week studies).
* Provides specialized studies such as juvenile toxicology in minipigs, crucial for assessing drug safety in pediatric populations.
* Performs embryofetal toxicology studies, including Fertility and Early Embryonic Development (FEED) studies, adhering to ICH guidelines.
* Offers supportive services including a fully equipped clinical pathology lab for hematology, biochemistry, coagulation, and urinalysis, validated for multiple species.
* Expertise extends to bioanalytical testing, drug formulation, and safety pharmacology as part of IND-enabling capabilities.
**Reputation / proof points**
* Supports the design, execution, and management of preclinical juvenile programs from exploratory to GLP-compliant phases.
* Collaborates closely with clients to ensure smooth transitions to first-in-human studies.
Scantox is a Contract Research Organization (CRO) specializing in toxicology and preclinical research, with a focus on supporting drug development from early stages through to regulatory submissions.
**Expertise & scope**
* Offers a comprehensive suite of toxicology services, including GLP-compliant studies, for preclinical drug development.
* Conducts general toxicology studies using rodent and non-rodent models, including Maximum Tolerated Dose (MTD) and Dose Range Finding (DRF) studies, as well as repeat-dose toxicity studies (e.g., 4-week, 13-week, 26-week, and 39-week studies).
* Provides specialized studies such as juvenile toxicology in minipigs, crucial for assessing drug safety in pediatric populations.
* Performs embryofetal toxicology studies, including Fertility and Early Embryonic Development (FEED) studies, adhering to ICH guidelines.
* Offers supportive services including a fully equipped clinical pathology lab for hematology, biochemistry, coagulation, and urinalysis, validated for multiple species.
* Expertise extends to bioanalytical testing, drug formulation, and safety pharmacology as part of IND-enabling capabilities.
**Reputation / proof points**
* Supports the design, execution, and management of preclinical juvenile programs from exploratory to GLP-compliant phases.
* Collaborates closely with clients to ensure smooth transitions to first-in-human studies.
Additional information
Scantox provides a range of toxicology services essential for regulatory submissions, including IND applications. Their capabilities cover acute and chronic toxicity studies, with specific expertise in juvenile and embryofetal toxicology. The company emphasizes collaboration with clients to tailor study designs and ensure compliance with international guidelines such as ICH. Their clinical pathology lab supports analyses across various species, and they can implement and validate new tests in cooperation with clients. Scantox also offers bioanalytical testing and drug formulation services, positioning them as a comprehensive partner for preclinical drug development.
Key Highlights
-
Offers GLP-compliant toxicology studies for preclinical drug development.
Source
“Scantox offers the full spectrum of toxicology services, including GLP.”
-
Specializes in juvenile toxicology studies using minipigs for pediatric drug safety assessment.
Source
“At Scantox, our preclinical juvenile toxicity studies are designed to bridge this gap, ensuring drugs are safe and effective for pediatric use before advancing to human trials.”
-
Conducts embryofetal toxicology studies adhering to international ICH guidelines.
Source
“Scantox provides three developmental and reproductive toxicology (DART) study types. They adhere to international ICH guidelines (e.g., ICH S5(R3)) for drug safety assessments.”
-
Provides comprehensive clinical pathology services including hematology, biochemistry, and urinalysis.
Source
“Included in the Scantox laboratory set up is a fully equipped clinical pathology lab, set up to enable analyses of all standard tests/biomarkers within hematology, biochemistry, coagulation and urinalysis...”
Certifications & Trust Signals
-
Operates as a Contract Research Organization (CRO) with expertise in toxicology and preclinical research.
Source
“As a leading CRO in toxicology and preclinical research, we prioritize efficiency and close collaboration with our clients to smoothly transition to first-in-human studies.”
Buyer Snapshot
Best for
- Companies requiring GLP-compliant toxicology studies for drug development.
- Sponsors needing specialized juvenile or embryofetal toxicology assessments.
- Organizations seeking integrated preclinical research support, including bioanalysis and clinical pathology.
How engagement typically works
- Collaborative, working as an extension of the client's team.
- Focus on efficiency and smooth transition to human trials.
- Customized study design based on client needs and regulatory requirements.
Typical deliverables
- GLP-compliant toxicology study reports.
- IND-enabling study packages.
- Clinical pathology analysis reports.
- Juvenile and embryofetal toxicology study data.
Good to know
- Best when requiring specialized toxicology expertise for drug safety assessments.
- Best when needing a CRO with experience in various animal models and study types.
HQ:
US
Languages:
English
Status:
listed
Services & Capabilities
Biocompatibility Testing (ISO 10993 Program)
Industries:
Medical Devices
Iso10993 Standards Supported:
ISO 10993-1, ISO 10993-5, ISO 10993-10, ISO 10993-11, ISO 10993-12, ISO 10993-18
Test Types Offered:
Cytotoxicity, Sensitization, Irritation, Systemic toxicity, Genotoxicity, Implantation, Hemocompatibility, Pyrogenicity, Biodegradation
Glp Compliant:
Yes
Has In House Toxicology:
Yes
Contact Types Supported:
Surface contact, External communicating, Implant
Duration Types Supported:
Limited (< 24h), Prolonged (24h - 30d), Permanent (> 30d)
Additional biocompatibility_testing Details
Iso10993 Standards Supported
ICH guidelines (e.g., ICH S5(R3))
Test Types Offered
General toxicology studies, Maximum Tolerated Dose (MTD) studies, Dose Range Finding (DRF) studies, Repeat-dose toxicity studies, Juvenile toxicology studies, Embryofetal toxicology studies, Fertility and early embryonic (FEED) studies, Clinical pathology analyses (hematology, biochemistry, coagulation, urinalysis), Flowcytometry, Aggregometry, ELISA.
Contact Types Supported
N/A
Duration Types Supported
Limited (< 24h) (e.g., DRF studies), Prolonged (24h - 30d) (e.g., 4-week studies), Permanent (> 30d) (e.g., chronic studies up to 12 months)
Lead Time Band
Start in 4-8 weeks
Quote SLA
3-5 business days
Sample Return Policy
Dispose
Minimum Project Size
Custom
Pricing Model
Per project
