The life science industry has long faced the lengthy and costly process of developing new drugs and medical devices: Digital Twin and Biosimulation are the key to cutting down time frames and costs in this area, with two trends pushing heavily in this direction: the regulatory tailwind (both the FDA and EMA are already endorsing these technologies) and the disruption the pandemic caused in pharma and Medtech R&D, paving the way to a new trial paradigm.
InSilicoTrials has considerable experience with regulatory agencies around the globe such as EMA and the FDA. We can therefore support our clients in their regulatory processes and ensure the documentation presented on their pathway towards compliance is scientifically focused and practical.