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TRA Testing
Toxicological Risk Assessments
At RQM+, we offer world-class toxicological risk assessments through our team at Jordi Labs, which brings together Ph.D. toxicologists and seasoned analytical chemists. Our integrated approach helps ensure your products are safe for human health and fully compliant with global regulations. We combine chemical composition analysis with detailed toxicological evaluation, providing robust, actionable insights tailored to meet the stringent demands of your industry.
Whether you're assessing medical devices, pharmaceutical packaging, or environmental health impacts, our comprehensive toxicology services offer precise evaluations backed by cutting-edge methodologies and regulatory expertise.
In-Depth Expertise for Holistic Risk Assessments
The stakes are high when evaluating the safety of materials in medical devices, pharmaceuticals, or consumer goods. RQM+, through Jordi Labs, offers a collaborative approach where Ph.D. toxicologists work alongside analytical chemists to:
- Identify hazardous compounds with pinpoint accuracy.
- Conduct dose-response assessments to evaluate potential exposure risks.
- Perform exposure assessments to understand the potential real-world impact.
- Deliver comprehensive risk characterization to inform regulatory strategies.
Our team understands that precision in chemical identification and risk assessment is critical for professionals focused on maintaining the highest standards of human health and environmental safety.
Comprehensive Applications for Diverse Industries
Our clients trust us to deliver assessments that not only meet regulatory requirements but also provide a deeper understanding of the chemicals at play. We provide toxicological risk assessments across multiple sectors
Our ISO 10993-compliant evaluations ensure that all chemical exposures are rigorously assessed for biocompatibility and patient safety.
We analyze leachables and extractables to mitigate the risk of contamination and ensure compliance with regulatory standards.
We assess materials for compliance with EU regulations such as EN 13130, ensuring safety for consumers.
Our services help identify and mitigate potential chemical hazards across a wide range of products.
Regulatory Compliance
In a fast-evolving regulatory landscape, compliance is non-negotiable. We help you stay ahead of regulatory shifts by ensuring that your toxicological risk assessments are compliant with:
- ISO 10993 for biological evaluation of medical devices.
- EU REACH and EN 13130 standards for chemical safety.
- FDA guidelines for chemical exposure and toxicology.
By partnering with RQM+, you’ll benefit from regulatory guidance tailored to the specific needs of toxicologists, chemical safety officers, and environmental health scientists, ensuring that your products not only meet but exceed industry standards.
Integrated Services for Comprehensive Evaluations
Our toxicological risk assessments are integrated with a range of analytical services to provide a full-spectrum understanding of product safety:
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Extractables and Leachables (E&L) Testing: We identify and quantify chemicals that could migrate from your products, ensuring all potential risks are accounted for.
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Chemical Characterization: Our advanced techniques, including mass spectrometry and chromatography, enable precise identification of materials at the molecular level.
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Elemental Impurities Testing: We screen for hazardous metals and other contaminants to ensure your product’s purity and safety.
Advanced Analytical Techniques for Reliable Risk Assessments
For toxicology professionals, confidence in the data is critical. RQM+, through Jordi Labs, uses cutting-edge analytical techniques to support toxicological evaluations:
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High Resolution Mass Spectrometry (HRAM-MS) for precise identification of chemical compounds.
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Chromatography (HPLC, GC) for accurate separation and quantification of complex mixtures.
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Spectroscopy and Elemental Analysis for detailed insights into chemical structure and potential contamination.
Our laboratory is equipped with the latest technologies to ensure that all data is reliable, reproducible, and ready for regulatory submission. We also go beyond basic toxicological assessments by employing advanced concepts such as threshold of toxicological concern (TTC), establishing safe thresholds for chemicals with limited toxicological data, and cohort of concern (CoC), identifying chemicals with heightened toxicity, including carcinogens and mutagens, and determining whether they exceed safe exposure levels. By applying these sophisticated toxicology methodologies, we provide nuanced assessments that enable your team to make informed, scientifically sound decisions.
Why RQM+ for Your Toxicological Risk Assessments?
At RQM+, our toxicology services are underpinned by deep technical expertise and a comprehensive understanding of global regulatory landscapes. Our team of Ph.D. toxicologists and analytical chemists works collaboratively to deliver rigorous assessments that meet the highest scientific and regulatory standards.
With former FDA and EU regulators on staff, we offer unparalleled insight into the evolving regulatory requirements, helping your products achieve compliance with confidence. From detailed chemical characterization to advanced toxicological evaluations, our integrated services ensure that every aspect of chemical safety is addressed, allowing your team to mitigate risks effectively and accelerate time to market. By partnering with RQM+, you’ll gain access to world-class expertise that helps you make informed, scientifically robust decisions at every stage of product development.
We are passionate about your success. Tell us more about your needs so we can help.
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