Regulatory Intelligence: drug, device and diagnostics development is an expensive, time-consuming and complex undertaking. Getting the regulatory strategy right, recognising the potential pitfalls and understanding the requirements for your specific product is of utmost importance.

We analyse your particular projects and help you to fully understand the regulatory environment, taking into account precedents and current regulatory thinking. In close co-operation with your team, we develop the specific road maps that apply to your projects.

We make a strategy in each stage of regulatory activities (Pre-submission, Submission, Assessment and post submission)