Biocompatibility Services
From Biological Risk to Regulatory Approval—Faster, Smarter, Compliant
Biocompatibility services are critical for demonstrating the biological safety, regulatory compliance, and market readiness of medical devices, pharmaceutical products, and combination products.
At ToxExel Solutions, we provide science-driven and regulator-accepted biocompatibility services designed to reduce unnecessary testing, accelerate approvals, and ensure compliance with ISO 10993 and global regulatory expectations.
Why Biocompatibility Services Matter
Regulatory authorities expect a risk-based and scientifically justified biocompatibility strategy—not simply a checklist of tests.
Without expert biocompatibility support, companies may face:
- Unnecessary testing costs and delays
- Regulatory objections due to insufficient justification
- Delayed product approvals
- Incomplete biological safety evaluations
Our biocompatibility services combine toxicology, risk assessment, and regulatory expertise to help you achieve compliant and efficient biological evaluation programs.
What You Get with Our Biocompatibility Services
- Optimized biocompatibility testing strategies
- Fully compliant Biological Evaluation Plans (BEP)
- Comprehensive Biological Evaluation Reports (BER)
- ISO 10993 toxicological risk assessments
- Faster regulatory approvals with fewer review questions
Our Core Biocompatibility Services
Biological Evaluation Plan (BEP) Development
- Risk-based strategies aligned with ISO 10993 requirements
- Endpoint selection based on device type, duration, and contact type
- Gap assessment and testing roadmap development
Biological Evaluation Report (BER)
- Comprehensive biological risk assessment
- Integration of test data, scientific literature, and toxicological evidence
- Final biological safety conclusions for regulatory submissions
ISO 10993 Toxicological Risk Assessment
- Chemical characterization interpretation (ISO 10993-18)
- Toxicological risk assessment (ISO 10993-17)
- Extractables and leachables safety evaluations
Biocompatibility Test Strategy Optimization
- Reduction of unnecessary in vivo studies
- Use of existing scientific data and literature
- Scientific justification for biocompatibility endpoints
Regulatory Submission Support
- Support for FDA, EMA, and global regulatory submissions
- Responses to regulatory questions and deficiencies
- Documentation review and compliance gap closure
Deliverables
- Biological Evaluation Plans (BEP)
- Biological Evaluation Reports (BER)
- ISO 10993 Toxicological Risk Assessments
- Chemical Characterization Interpretations
- Regulatory Response and Justification Documents