At Computational Life, we understand the intricacies of regulatory submissions for drugs and medical devices. Our suite of services is designed to guide you through each step of the approval process with expertise and precision.

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Preliminary Consultation: Laying the Groundwork
Our journey begins with an in-depth consultation. Leveraging our theoretical and practical knowledge of regulatory procedures, we help you navigate the complex landscape of notified bodies. This early stage is crucial for setting a strategic path, aligning your goals with regulatory expectations.

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In-Silico Evidence Generation: Pioneering Simulation Techniques

• Pre-Clinical Scenario Simulation: We create simulations that replicate bench-tests or animal models, offering valuable insights before actual physical testing.

• Clinical Scenario Modeling: Our models extend to individual and population studies, providing a robust foundation for clinical decision-making.

• In-Silico Clinical Trials: Experience the future of clinical research with our in-silico trials. These simulations offer a cost-effective, efficient, and ethically responsible way to predict clinical outcomes and assess drug/device efficacy.

Documentation Support: Ensuring Compliance and Precision
The final and crucial phase is the production of documentation for submission. Our team works diligently to ensure that every report and dossier is comprehensive, clear, and fully compliant with the latest guidelines, including the FDA's "Assessing the Credibility of Computational Modeling and Simulation in Medical Device Submissions" guidance. From start to finish, we stand by our commitment to precision and compliance, ensuring your journey to market is as smooth as possible.

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Discover how our Regulatory Support Services can pave your way to success. Let's embark on this journey together.