In evaluating the requirements of a regulatory agency the number of documents with relevant information is overwhelming. We most often rely on guidance documents and other official publications but we’re limited by our ability to search across these sources quickly.
Our technology allows users to search all relevant sources across multiple agencies in the same place and at the same time.
To establish a strong development strategy, we need to find the relevant gaps in the standard of care while taking into account products that might be able to address them. These answers are found in approved product labels, review packages, scientific publications and clinical trial registries.
Our technology connects the important information found in these sources to deliver a comprehensive view of the opportunities and risks.
The regulatory authorities strongly encourage discussing with them key decisions along the development path. In these interactions, the development team has the opportunity to get early feedback on their progress and next steps. Records of these interactions are available but not easily accessible.
To help teams learn from these interactions and better prepare for their meetings, our technology makes these interactions fully searchable and provides the users with sufficient context to capture all relevant information.