All medical devices and pharmaceutical packaging systems must undergo rigorous biological evaluations during early-stage development. As a form of toxicological risk assessment (TRA), these evaluations are designed to establish the risk of exposure to potentially hazardous substances used in the manufacture of the device/system and to determine the likelihood that exposure will lead to acute or chronic effects. Essentially, biological and toxicological assessments are a key form of risk management process designed to ensure that products carry negligible health risks and are safe for their intended use.
At Jordi Labs, we offer support at the pre-clinical validation stage, helping you plan and carry out biological evaluations during the design phase of development. We conduct various in vitro and in vivo tests to verify the biocompatibility of candidate materials for biopharmaceutical and medical products and can assist with key documentation for final products.
The so-called “Big Three” biological assessments involve tests for cytotoxicity, skin sensitization, and irritation testing. But there is no rinse-and-repeat approach to biological evaluations, and proposed actions will vary depending on the nature of the product, the novelty of materials used in its fabrication, and the requirements of relevant legislation. We are well-versed in working within distinct regulatory frameworks, providing chemical characterization testing services which go beyond the benchtop.
Looking for Support with Biological Evaluations?
Jordi Labs is one of the largest chemical testing partners in the US, providing a range of consulting services to technical product management in critical fields. Through our biological evaluation service, we aim to assist customers with product design, material selection, chemical testing, protocol design, and more, from initial research and development through to end-product documentation. If you are interested in our biological evaluation services, why not contact a member of the Jordi team today?
If you are looking for support further down the product development pipeline, refer to our regulatory consulting page.