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, ensuring product safety and regulatory compliance.

**Expertise & scope**
* Conducts preclinical medical device testing and consulting.
* Offers specialized guidance for device development.
* Performs approximately 6,500 studies annually with 150 dedicated specialists.
* Provides based in vitro alternatives.

**Reputation / proof points**
* Over 40 years of experience in preclinical medical device testing and consulting.

Additional information

The content reviewed indicates a significant transition for Labcorp's medical device testing business, which has joined NAMSA as of January 7, 2026. While Labcorp remains committed to ongoing studies during this period, potential clients should note this change when engaging services previously associated with Labcorp's early development medical device testing. This transition may impact service continuity or point of contact for certain testing needs.

Key Highlights

  • Over 40 years of experience in preclinical medical device testing and consulting. Source
    “40+ years of experience in preclinical medical device testing and consulting”
  • Employs 150 dedicated specialists conducting approximately 6,500 studies per year. Source
    “Our 150 dedicated specialists conduct ~6,500 studies per year*”
  • Offers specialized guidance to advance device development. Source
    “Specialized guidance to advance your device development so you gain clarity in complexity”
  • Provides based in vitro alternatives. Source
    “based in vitro alternatives available”

Certifications & Trust Signals

  • 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 seeking biocompatibility testing.
  • Pharmaceutical companies requiring product safety assessments.
How engagement typically works
  • Project-based testing services.
  • Consulting for device development.
Typical deliverables
  • Biocompatibility test reports.
  • Preclinical study data.
  • Regulatory compliance guidance.
Good to know
  • Best when engaging with established medical device or pharmaceutical development pipelines.
HQ: USA
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, Irritation, Systemic toxicity, Genotoxicity, Implantation, Hemocompatibility, Pyrogenicity
Is Accredited: Yes
Accreditation Body: A2LA
Glp Compliant: Yes
Has In House Toxicology: Yes
Toxicology Capabilities: Toxikon offers a comprehensive suite of biocompatibility testing services, including cytotoxicity, sensitization, irritation, systemic toxicity, genotoxicity, implantation, hemocompatibility, pyrogenicity, carcinogenicity, reproductive toxicity, biodegradation, and pharmacokinetics. They also support various ISO 10993 standards and USP <87>/<88>.
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 submitted with a completed test request form and a certificate of analysis.
Sample Return Policy: Return
Nda Support: Yes
Minimum Project Size: $10-25k
Lead Time Band: Start in 4-8 weeks
Quote SLA: 3-5 business days

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
Request quotes
Cruxi - Regulatory Compliance Services