Toxikon’s Technical Consulting Group provides Sponsors with dedicated resources to develop solutions that advance your product innovation. Our network of scientists, engineers, and regulatory experts will collaborate with you to maximize efficiency, reduce risk, and accelerate your time to market.
ToxSMART just makes sense. Either as a standalone service having our experts assist you with your product development process or to complement many of our laboratory services, including a full range of preclinical toxicology capabilities, surgical efficacy programs, biocompatibility, microbiology, and globally recognized analytical chemistry capabilities in Chemical Characterization and Extractable & Leachable determination. ToxSMART provides you access to our experience of assessing over 6,000 different materials each year, our interaction with regulatory agencies, and first-hand participation in setting standards such as ISO 10993, AAMI, and USP. This extends our expertise into your team, enabling you to bring your product to market successfully.
Take control of your regulatory strategy and partner with the experts. A pre-IND meeting is now a requirement to getting your product to market for many of the new and innovative therapies being developed today. Program success is often determined/ correlated by Key Opinion Leaders (KOLs) and agency reviewers interfacing with each other through frequent and early communications. Interacting with the agencies through Subject Matter Experts (SMEs) help you navigate this complex landscape.
With the innovation of novel materials, unique applications, and cutting-edge products, it is more critical now in today’s regulatory landscape to provide expert assessments of the safety and efficacy of your product. Last year, an FDA Reviewer indicated in a public forum that the second most important document reviewed in a 510K or PMA submission of a medical device was the Toxicological Risk Assessment.
- Toxicological Risk Assessment
- GAP Analysis
- Regulatory Strategy
- Pre-IND Support
- Biocompatibility through Risk Management
- Clinical & Anatomical Pathology
- Material Science
- Analytical Chemistry
- Chemical Characterization
- Extractables & Leachables
- Antimicrobial Activity
- Reprocessing Validation (Reusable Device)
- Surgical Model Development
- Preclinical & Veterinary
- IFU/DFU Consulting
- Human Factors for Medical Device
- Program/Project Management
- Literature Search