Preclinical Safety Consulting
An initial consultation will identify project goals and help us understand your product. With these goals in mind, our experts will construct a test strategy report, which includes a full description of the device, with the recommended biocompatibility and chemistry testing to assist in preparing pre-market submissions. These strategies will leverage regulatory guidance documents and pre-existing data, as well as any additional study proposals designed to assess clinical efficacy and/or safety.
The objective is always to provide test results that are right the first time and have the highest likelihood of approval.