A regulatory strategy is an important tool to help navigate the complex regulatory landscape and ensure that the product meet the necessary requirements for market authorisation. By including regulatory aspects early on in the project, the path to market access can be influenced and time to market minimized.
The specific contents and details of the regulatory plan varies depending on the TPP, target markets, and applicable regulations. Regulatory requirements may differ across countries or regions, the plan should be tailored to the company’s unique circumstances and objectives. Additionally, regulatory plans should be regularly reviewed and updated as new data emerges, regulatory landscapes evolve, or when new products or markets are introduced.
We believe that progress in research and development comes from teamwork, and we are committed to bring the regulatory aspects to the table. We will analyse the regulatory environment and precedence, scientific data and current regulatory thinking. We assess preclinical, clinical and CMC data and development plans from a regulatory perspective, identifying opportunities and issues and providing a regulatory strategy moving forward. We will help you build a regulatory plan integrated in your product development plans to support EU and US approval.