Defensible, structured, and submission-ready
Biological Evaluation of Medical Devices
End-to-end support for biological evaluation, aligned with international regulatory standards.
What we do
- Develop evaluation strategies
- Assess extractables and leachables
- Perform toxicological risk assessments
- Prepare regulatory documentation
Key deliverables
- Biological Evaluation Plan (BEP)
- Biological Evaluation Report (BER)
- Toxicological Risk Assessment (TRA)
- Test strategy development.
From data to transparent safety conclusions
Toxicological Assessment of Chemicals and Materials
Comprehensive safety evaluation across industrial, pharmaceutical, and specialty applications.
What we do
- Hazard identification
- Dose-response analysis
- Risk characterization
- Weight-of-evidence evaluation
Understanding impact beyond controlled conditions
Environmental Toxicology and Ecotoxicology
Assessment of substance fate, behavior, and impact across environmental systems.
Focus areas
- Aquatic and soil systems
- Exposure pathways
- Long-term and emerging risks
Clarity where standard approaches are not enough
Scientific Advisory
Independent expertise for complex toxicological challenges.
We support
- Study design and strategy
- Data interpretation
- Regulatory communication
Scientific Rigor
Methodologically sound and
evidence-based
Clarity
Structured,
transparent interpretation
Practical Relevance
Aligned with
real-world decisions
Extended expertise
through collaboration
We operate through a trusted network of specialists, ensuring access to the appropriate expertise for each project—whether highly specialized or interdisciplinary
