Regulatory support and expertise to navigate treatment approvals We have broad experience in developing and supporting companion diagnostics and submissions for CE marking. Our flexible business models include partnering with pharmaceutical and in vitro diagnostic (IVD) manufacturers to provide customized analytical and clinical validation services for Premarket Approval (PMA) approvals. Additionally, we have in-house capability to support our own PMA submissions. Our team can support your regulatory needs by filing risk assessments and Investigational Device Exemption (IDE), PMA, Institutional Review Board (IRB) and CE marking submissions. Our quality systems are designed to ensure compliance with applicable regulatory requirements for drug and diagnostic approvals. Together with our expertise in clinical trial testing, we aim to be your partner of choice for integrated solutions from pre IDE to PMA submission and approval.