Let our expertise help you whether it is an emergency for a fielded product or risk assessing a mutagenic impurity.

Comprehensive, peer-reviewed TRAs that meet the highest global standards (e.g. ISO 10993-17, ICH M7,  USP <1663>, USP <1664>, etc. includes QSAR and read across methodologies). This includes inhalation exposure toxicology.

Strategic BEPs and BERs designed to streamline PMA, 510(k), De Novo, IDE, etc. submissions while minimizing redundant testing.

Niche expertise in ISO 18562, ensuring the safety of respiratory devices through VOC and particulate analysis.

Let us help you identify the right CRO for your needs, within your timeframe and budget, we can act as the sign-off on the protocols, the reports, and everything in between. 

ISO 10993-1

ISO 10993-3

ISO 10993-5

ISO 10993-6

ISO 10993-7

ISO 10993-10

ISO 10993-11

ISO 10993-23

ISO 10993-33

Custom assays and protocol development/review

Litigation support and analytical toxicology oversight for high-stakes medical device safety cases or human-health exposure assessments.

We can help you choose biocompatible materials using a risk-based approach, aiming to minimize toxicological risks from materials, colorants, additives, and processing aids/residues.

We can develop and design appropriate experimental paradigms that meet the requirements of ISO 10993-18 while also holding up to regulatory scrutiny.

We provide approaches for comparative analysis, orthogonal evaluations, material changes, supplier transitions, manufacturing process modifications, and everything in between so you are not always in a state of testing.