Delivery of Services Through Experienced Advisors

Our staff have previously worked as regulatory assessors/inspectors at the MHRA and EMA. They have reviewed all types of applications from full new applications to post-approval variations, for some of the biggest pharmaceutical companies in the market.

 

Drawing from this background we aim to provide our clients with a clear understanding of which regulatory strategy can be achieved, which requirements need to be negotiated and which areas will face resistance. Our clear and honest appraisals provide our clients with clear choices to review and balance their strategy against their individual circumstances and project goals.

Contrary to popular belief, there is often room for negotiating with the regulators.  Often, decisions can be subjective and policies and interpretations are open to debate. However with experienced advisors you will be best place to understand the dynamics of how regulatory decisions are made, when to engage with the regulatory agencies and how to progress your submissions to seek a positive outcome.