WuXi AppTec is here to help you navigate global regulations by working with you to design optimal preclinical testing strategies for successful submission, respond to regulatory inquiries and support your commercial products. We have developed a database of reviewer questions, which further enhances our ability to identify new trends and quickly pass this learning on to our customers.Our team will support you with a strategy that meets your individual needs and establishes the best path forward, avoiding potential roadblocks that can result in costly delays. We stand behind our testing, and fully support our customers by addressing any regulatory inquires that may arise. Additionally, we can identify gaps in testing or compliance, and help you to develop a remedy to bring your testing up to date or resolve complicated regulatory concerns.
Our active participation on global standards committees allows us to track and predict how regulators are interpreting new trends and regulatory changes. Using our consultation services provides you with direct access to the individuals at the forefront of medical device regulations, with subject matter expertise spanning custom in vivo models, reprocessing, package testing, osteoinduction, biocompatibility, histopathology, extractables / leachables, and toxicological risk assessments and more. Our team of consulting experts includes:
Leaders and active participants on international standards committees, including multiple ISO 10993 committees, ASTM, AAMI and USP
21+ Ph.D. and post-doctorate level experts, including a former FDA reviewer