Toxikon Corporation
Toxikon Corporation is a leading provider of biocompatibility testing services for medical devices and pharmaceuticals. They ensure product safety and regulatory compliance.
Toxikon Corporation specializes in comprehensive biocompatibility testing, offering a full suite of services to meet the rigorous demands of the medical device and pharmaceutical industries. Their expertise ensures that products are safe for human use and comply with global regulatory standards such as ISO 10993. They are dedicated to providing reliable data and expert consultation to support product development and market entry. With a commitment to scientific excellence and client success, Toxikon Corporation partners with manufacturers to navigate the complex landscape of regulatory requirements. Their state-of-the-art facilities and experienced team deliver accurate and timely results, facilitating the approval process for innovative healthcare solutions. They are a trusted resource for biocompatibility assessments, contributing to the safety and efficacy of medical products worldwide.
About
**Who they are**
Toxikon Corporation is a provider of biocompatibility testing services for medical devices and pharmaceuticals, focused on ensuring product safety and regulatory compliance.
**Expertise & scope**
* Services include biocompatibility testing for medical devices and pharmaceuticals.
* Focus on ensuring product safety and regulatory compliance.
**Reputation / proof points**
* Possesses over 40 years of experience in preclinical medical device testing and consulting.
* Employs 150 dedicated specialists.
* Conducts approximately 6,500 studies per year.
* Offers specialized guidance for device development.
Toxikon Corporation is a provider of biocompatibility testing services for medical devices and pharmaceuticals, focused on ensuring product safety and regulatory compliance.
**Expertise & scope**
* Services include biocompatibility testing for medical devices and pharmaceuticals.
* Focus on ensuring product safety and regulatory compliance.
**Reputation / proof points**
* Possesses over 40 years of experience in preclinical medical device testing and consulting.
* Employs 150 dedicated specialists.
* Conducts approximately 6,500 studies per year.
* Offers specialized guidance for device development.
Additional information
Toxikon Corporation's services are geared towards medical device and pharmaceutical manufacturers requiring rigorous testing to meet safety and regulatory standards. Their extensive experience, evidenced by over 40 years in the field, suggests a deep understanding of the complexities involved in preclinical testing. The company's capacity to conduct a significant volume of studies annually, supported by a team of 150 specialists, indicates a robust operational capability. Buyers can expect tailored guidance to navigate the device development process, aiming for clarity and efficiency in achieving compliance.
Key Highlights
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Over 40 years of experience in preclinical medical device testing and consulting.
Source
“40+ years of experience in preclinical medical device testing and consulting”
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Employs 150 dedicated specialists to conduct testing.
Source
“Our 150 dedicated specialists conduct ~6,500 studies per year*”
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Conducts approximately 6,500 studies annually.
Source
“Our 150 dedicated specialists conduct ~6,500 studies per year*”
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Provides specialized guidance to advance device development.
Source
“Specialized guidance to advance your device development so you gain clarity in complexity”
Certifications & Trust Signals
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Over 40 years of experience in preclinical medical device testing and consulting.
Source
“40+ years of experience in preclinical medical device testing and consulting”
Buyer Snapshot
Best for
- Medical device manufacturers
- Pharmaceutical companies
- Companies seeking biocompatibility testing
How engagement typically works
- Project-based testing
- Consultative guidance
Typical deliverables
- Biocompatibility test reports
- Regulatory compliance assessments
- Preclinical testing data
Good to know
- Best when requiring specialized biocompatibility testing for product safety and regulatory approval.
HQ:
USA
Languages:
English
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, Irritation, Systemic toxicity, Genotoxicity, Implantation, Hemocompatibility, Pyrogenicity
Is Accredited:
Yes
Accreditation Body:
A2LA
Glp Compliant:
Yes
Has In House Toxicology:
Yes
Toxicology Capabilities:
In-house toxicology capabilities include: Acute, Subchronic, Chronic, Reproductive and Developmental Toxicity, Carcinogenicity, Mutagenicity, Genotoxicity, Immunotoxicity, Local Tolerance, Safety Pharmacology, Drug Metabolism and Pharmacokinetics (DMPK), and Bioanalysis.
Contact Types Supported:
Surface contact, External communicating, Implant
Duration Types Supported:
Limited (< 24h), Prolonged (24h - 30d), Permanent (> 30d)
Rush Available:
Yes
Sample Requirements:
Samples must be sterile and provided in appropriate containers. Specific quantities and preparation methods will be discussed on a case-by-case basis.
Sample Return Policy:
Both options
Nda Support:
Yes
Minimum Project Size:
$10-25k
Additional biocompatibility_testing Details
Iso10993 Standards Supported
ISO 10993
Test Types Offered
Biocompatibility testing
Contact Types Supported
Surface contact, External communicating, Implant
Duration Types Supported
Limited (< 24h), Prolonged (24h - 30d), Permanent (> 30d)
Lead Time Band
Start in 4-8 weeks
Quote SLA
3-5 business days
Sample Return Policy
Return
Minimum Project Size
$50k+
Pricing Model
Per project
