Beyond the traditional regulatory function of preparing and submitting applications to Regulatory Agencies and Ethics Committed /IRB across the globe, the service involves keeping the leadership up-to-date about current regulations changes that may affect the approval of the clinical studies. The Regulatory Intelligence contributes to help start-up teams provide the best quality submissions to agencies and EC/IRB within the smoothest process.
Project Life Cycle
To guarantee your project success, all studies follow a structured approach fro the final delivery. This allows everyone working on the project to identify how the project is progressing, with clearly defined activities and outputs for each phase. Aids communication and provides a framework for the project that is visible and understood by all members of the project and customer. The phases within the project life cycle provide an understanding of the evolution of the project, being able to identify areas that need greater attention at different times such as risk management and evaluation reviews.
Research Regulatory Library:
Our Research Regulatory Library is intended to serve as a resource centre for a variety of different regulations and issues of interest to he clinical research for pharmaceutical, medical device and biotechnology companies.