Our team of regulatory experts have navigated themselves around the complexities of Regulation (EU) 536/2014 (Clinical Trial Regulation) and the working practices of the EMA Clinical Trial Information System (CTIS).

Our strong team of professionals are able to expedite timelines with our methodical planning strategies defining your deliverables. Applying dedication to your project assessing at every stage of the regulatory pathway so that nothing is left to chance.

Ensuring regulatory approvals are achievable with risk mitigation strategies applied and never leaving behind the 'quality by design' principles and the integrity of the project.