• Risk, vigilance, and remediation under IVDR

    The In Vitro Diagnostics Regulation (IVDR) — which goes into effect on May 26, 2022 — will have a lasting impact on the entire in vitro diagnostics (IVD) lifecycle, from development through clinical investigations and regulatory approval.

  • Managing COVID disruptions within IVDR timelines

    The COVID-19 pandemic has greatly impacted the IVD industry, including travel and social distancing restrictions, creating hassles and stalling NB designation processes.

  • Exploring the benefits of biotech partnerships

    The biotechnology sector is leading the way in developing innovative therapies that will address the unmet needs of many challenging diseases.

  • Cancer research post-COVID-19

    The COVID-19 pandemic has been a catalyst for change in cancer research, forcing a shift towards remote monitoring, virtual arms and other uses of digital tools as global lockdowns reduce the ability of patients to go to clinics.

  • The shifting diagnostics regulatory landscape amid COVID-19

    For IVD manufacturers, the emergence of a novel virus is challenging as the detection of such viruses require quickly developed, novel diagnostic solutions.