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, dedicated to supporting clients through the drug development process. They focus on providing comprehensive services to ensure product safety and regulatory compliance.
**Expertise & scope**
* Offers a full spectrum of toxicology services, including GLP-compliant studies, supporting every step of preclinical drug development.
* Conducts general toxicology studies in rodent and non-rodent species, including Maximum Tolerated Dose (MTD) and Dose Range Finding (DRF) studies.
* Performs repeat-dose toxicity studies, such as 4-week, 13-week, 26-week (rodent), and 39-week (non-rodent) studies, as well as chronic studies up to 6-12 months.
* Specializes in Investigational New Drug (IND)-enabling studies, safety pharmacology, and bioanalytical testing.
* Provides juvenile toxicology studies in minipigs to assess drug safety for pediatric trials, adhering to FDA and EMEA guidelines.
* Conducts embryofetal toxicology studies, including Fertility and Early Embryonic Development (FEED) studies, following ICH guidelines.
* Offers comprehensive clinical pathology analyses in hematology, biochemistry, coagulation, and urinalysis, validated for relevant species.
**Reputation / proof points**
* Leverages decades of in-depth experience in key service areas.
* Supports the design, execution, and management of preclinical programs from exploratory to GLP-compliant phases.
Scantox is a Contract Research Organization (CRO) specializing in toxicology and preclinical research, dedicated to supporting clients through the drug development process. They focus on providing comprehensive services to ensure product safety and regulatory compliance.
**Expertise & scope**
* Offers a full spectrum of toxicology services, including GLP-compliant studies, supporting every step of preclinical drug development.
* Conducts general toxicology studies in rodent and non-rodent species, including Maximum Tolerated Dose (MTD) and Dose Range Finding (DRF) studies.
* Performs repeat-dose toxicity studies, such as 4-week, 13-week, 26-week (rodent), and 39-week (non-rodent) studies, as well as chronic studies up to 6-12 months.
* Specializes in Investigational New Drug (IND)-enabling studies, safety pharmacology, and bioanalytical testing.
* Provides juvenile toxicology studies in minipigs to assess drug safety for pediatric trials, adhering to FDA and EMEA guidelines.
* Conducts embryofetal toxicology studies, including Fertility and Early Embryonic Development (FEED) studies, following ICH guidelines.
* Offers comprehensive clinical pathology analyses in hematology, biochemistry, coagulation, and urinalysis, validated for relevant species.
**Reputation / proof points**
* Leverages decades of in-depth experience in key service areas.
* Supports the design, execution, and management of preclinical programs from exploratory to GLP-compliant phases.
Additional information
Scantox supports various routes of administration for toxicology studies, including oral (gavage, capsules, diet), dermal, intramuscular, subcutaneous, and intravenous. They can fit animals with vascular catheters for easier dosing or blood sampling. For clinical pathology, they analyze samples from studies performed at Scantox facilities and also offer analyses on samples from studies conducted at client facilities. They are equipped to implement and validate new clinical pathology tests in cooperation with clients.
Key Highlights
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Offers a full spectrum of toxicology services, including GLP-compliant studies for preclinical drug development.
Source
“Scantox offers the full spectrum of toxicology services, including GLP. We support every step of preclinical drug development.”
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Specializes in IND-enabling capabilities, encompassing toxicity, safety pharmacology, and bioanalytical testing.
Source
“This includes everything from lead candidate optimization, toxicity, and safety testing to bioanalytical testing and dose formulation.”
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Conducts juvenile toxicology studies in minipigs to ensure drug safety for pediatric trials, adhering to FDA and EMEA guidelines.
Source
“According to FDA and EMEA guidelines, juvenile animal toxicity studies are mandatory when existing data cannot confirm a drug’s safety for pediatric trials.”
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Provides embryofetal toxicology studies, including Fertility and Early Embryonic Development (FEED) studies, aligned with 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.”
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Features a fully equipped clinical pathology lab for hematology, biochemistry, coagulation, and urinalysis, validated for relevant species.
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
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Leverages decades of in-depth experience in key service areas for project success.
Source
“The Scantox team leverages its advanced program management skills and decades of in-depth experience in key service areas to ensure your project’s success.”
Buyer Snapshot
Best for
- Companies requiring comprehensive preclinical toxicology testing.
- Sponsors needing IND-enabling studies and regulatory support.
- Developers of pediatric drugs requiring specialized juvenile toxicology assessments.
How engagement typically works
- Collaborative, client-focused approach.
- Integrated program management.
- Customized study designs based on client needs and regulatory guidelines.
Typical deliverables
- GLP-compliant toxicology study reports.
- IND-enabling study packages.
- Clinical pathology analysis reports.
- Juvenile and embryofetal toxicology data.
Good to know
- Best when clients have specific drug candidates requiring rigorous safety evaluation.
- Requires clear justification for study designs, especially for juvenile toxicology.
HQ:
US
Languages:
English
Claim status:
Listed
Services & Capabilities
Biocompatibility Testing (ISO 10993 Program)
Industries:
Medical Devices
Pricing model:
Custom pricing
Iso10993 Standards Supported:
ISO 10993-1, ISO 10993-5, USP <87>, USP <88>
Test Types Offered:
Cytotoxicity, Genotoxicity, Systemic toxicity, Implantation, Hemocompatibility, 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)
Toxicology Capabilities:
Scantox offers a comprehensive suite of toxicology services, including in vitro and in vivo testing, to support medical device development and regulatory submissions. Their expertise covers a wide range of toxicological endpoints, ensuring thorough evaluation of device safety.
Lead Time Band:
Start in 4-8 weeks
Quote SLA:
3-5 business days
Rush Available:
Yes
Sample Requirements:
Samples must be sterile and provided in appropriate containers. Specific quantities and preparation methods will be communicated based on the tests requested.
Sample Return Policy:
Both options
Nda Support:
Yes
Minimum Project Size:
$25-50k
Regions Served:
North America, Europe, Asia
Additional biocompatibility_testing Details
Iso10993 Standards Supported
ICH S5(R3)
Test Types Offered
General toxicology, Maximum Tolerated Dose (MTD) studies, Dose Range Finding (DRF) studies, Repeat-dose toxicity studies (4-week, 13-week, 26-week, 39-week, chronic), IND-enabling studies, Safety pharmacology, Bioanalytical testing, Juvenile toxicology studies, Embryofetal toxicology studies (FEED), Clinical pathology (hematology, biochemistry, coagulation, urinalysis, flowcytometry, aggregometry, ELISA)
Contact Types Supported
Surface contact, External communicating, Implant
Duration Types Supported
Limited (< 24h), Prolonged (24h - 30d), Permanent (> 30d)
Lead Time Band
Start in 0-2 weeks
Quote SLA
< 24 hours
Sample Return Policy
Return, Dispose, Both options
Minimum Project Size
Custom
Pricing Model
Custom
