UK specialists

We are specialists in UK medicines regulation, with deep experience working with the MHRA, particularly in the post-Brexit environment.

We have supported clients through UK-specific regulatory changes, including the implementation of the Windsor Framework, helping navigate evolving requirements and maintain progress across submissions and lifecycle activities.

Our team has direct experience engaging with the MHRA, including Scientific Advice Meetings (SAMs), and a strong understanding of how the agency reviews and assesses applications. This allows us to provide practical, well-informed guidance when planning submissions and interactions.

Our team includes an ex-MHRA assessor, bringing valuable insight into regulatory expectations, review processes and decision-making.

We are multi award winners for our communications campaign on the Windsor Framework.