Risk management in medical and pharmaceutical product development is a complex process. It requires careful consideration of the biological risks posed by any candidate materials, and an evaluation of potentially critical properties such as genotoxic and non-genotoxic carcinogenicity, systemic toxicity, irritation and sensitization potential, pyrogenicity, and hemocompatibility. These biological evaluations are an integral part of the risk assessment process for medical devices and pharmaceutical packaging systems.
Biological evaluation plans are established and carried out to assess the safety of a given product from a biocompatibility perspective. Evaluations typically include reviews of materials of construction and available biological safety data, a series of biological and chemical tests, and toxicological risk assessments of testing data. The approaches are prescribed by established regional and international standards, such as ISO 10993, regional compendia, and ICH guidelines. The principal goal of any such evaluation is to prevent harm to patients from biological risks inherent in the product.
At Jordi Labs, we have extensive experience providing expert regulatory consultations and toxicological risk assessments. Our aim is to provide end-to-end support for valued customers, from the earliest stages of product development through to regulatory submissions support. We provide four core services when it comes to biological evaluation consulting:
- Product development strategy
- Biological evaluations (In-vitro & In-vivo testing)
- Regulatory consulting
- Toxicological Risk Assessments
Looking for Support with Biological Evaluations?
Jordi Labs provides a wide range of pre-clinical testing services designed to help our partners realize the potential of their own products. We can help with product design, material selection, chemical testing, protocol design, and more, with an ever-growing team of Ph.D. chemists ready and available to provide innovative solutions to your unique problems. If you are interested in our biological evaluation services, why not contact a member of the Jordi team today?